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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, surgical, general & plastic surgery
510(k) Number K812388
Device Name SURGICAL PAWS
Applicant
BERKELEY MEDEVICES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BERKELEY MEDEVICES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received08/20/1981
Decision Date 11/16/1981
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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