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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 K913302
Device Name DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
Applicant
CARWILD CORP.
SEAPORT CAMPGROUND RD.
P.O. BOX 512
OLD MYSTIC,  CT  06372
Applicant Contact JOEL S WILDSTEIN
Correspondent
CARWILD CORP.
SEAPORT CAMPGROUND RD.
P.O. BOX 512
OLD MYSTIC,  CT  06372
Correspondent Contact JOEL S WILDSTEIN
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/25/1991
Decision Date 07/23/1992
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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