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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutter, Surgical
510(k) Number K821122
Device Name OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT
Applicant
Conphar, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Conphar, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
FZT  
Date Received04/20/1982
Decision Date 05/07/1982
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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