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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ptfe/Carbon-Fiber
510(k) Number K861806
Device Name MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
Applicant
Medcomp Technologies, Inc.
2555 Baird Rd.
Penfield,  NY  14526
Applicant Contact WILDEMAN
Correspondent
Medcomp Technologies, Inc.
2555 Baird Rd.
Penfield,  NY  14526
Correspondent Contact WILDEMAN
Regulation Number878.3500
Classification Product Code
KDA  
Date Received05/09/1986
Decision Date 05/23/1986
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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