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Cardiovascular Devices; Reclassification of External Cardiac Compressor

Document ID: FDA-2012-N-1173-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-00085
CFR Citation: 21 CFR Part 870
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: January 08 2013, at 12:00 AM Eastern Standard Time
Start-End Page: 1162 - 1166
Page Count: 5
Comment Start Date: January 8 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: April 8 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Circulation

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Reference 2 Mechanical Versus Manual Chest Compressions for Cardiac Arrest (Review)

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Reference 3 Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff

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Comments

   
Total: 4
Laerdal Medical AS - Comment
Posted: 04/16/2013     ID: FDA-2012-N-1173-0004

Apr 08,2013 11:59 PM ET
Kelly Kehoe - Comment
Posted: 04/16/2013     ID: FDA-2012-N-1173-0002

Apr 08,2013 11:59 PM ET
Public Citizen - Comment
Posted: 04/16/2013     ID: FDA-2012-N-1173-0005

Apr 08,2013 11:59 PM ET
Barbara Jean Kelly - Comment
Posted: 04/16/2013     ID: FDA-2012-N-1173-0003

Apr 08,2013 11:59 PM ET

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