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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 K853965
Device Name NEOGUARD CHEST PERCUSSOR
Applicant
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Applicant Contact JOEL N HELFER
Correspondent
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Correspondent Contact JOEL N HELFER
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/26/1985
Decision Date 12/03/1985
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
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