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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K946083
Device Name FLUTTER(R)
Applicant
Bradstreet Clinical Research Assoc., Inc.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Applicant Contact PATRICIA W BRADSTREET
Correspondent
Bradstreet Clinical Research Assoc., Inc.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Correspondent Contact PATRICIA W BRADSTREET
Regulation Number868.5665
Classification Product Code
BYI  
Date Received12/13/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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