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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, surgical, instrument
510(k) Number K840976
Device Name VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
Applicant
CARAPACE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CARAPACE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
FSM  
Date Received03/06/1984
Decision Date 05/31/1984
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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