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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K932016
Device Name TRACHEOSTOMY CARE TRAY
Applicant
CLINIPAD CORP.
66 HIGH ST.
P.O. BOX 387
GUILFORD,  CT  06437
Applicant Contact PATRICIA STAWARZ
Correspondent
CLINIPAD CORP.
66 HIGH ST.
P.O. BOX 387
GUILFORD,  CT  06437
Correspondent Contact PATRICIA STAWARZ
Regulation Number868.5800
Classification Product Code
JOH  
Date Received04/23/1993
Decision Date 11/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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