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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K841320
Device Name PERCUTANEOUS TRIG. FINGER RELEASE KNIFE
Applicant
Anapach Effort, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Anapach Effort, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GES  
Date Received04/02/1984
Decision Date 04/24/1984
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
Predetermined Change
Control Plan Authorized		 No
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