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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K935882
Device Name TONSIL SPONGES
Applicant
MCNEIL HEALTHCARE, INC.
P.O. BOX 964
WATERFORD,  CT  06385
Applicant Contact TIMOTHY D MCNEIL
Correspondent
MCNEIL HEALTHCARE, INC.
P.O. BOX 964
WATERFORD,  CT  06385
Correspondent Contact TIMOTHY D MCNEIL
Regulation Number878.4450
Classification Product Code
GDY  
Subsequent Product Code
KBM  
Date Received12/09/1993
Decision Date 01/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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