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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ligature Passing And Knot Tying
510(k) Number K841617
Device Name STROVER HOOK
Applicant
PLASTAFIL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PLASTAFIL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
HCF  
Date Received04/19/1984
Decision Date 08/27/1984
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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