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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scalpel, One-Piece
510(k) Number K820730
Device Name MICRO CISE DIAMOND SCALPEL
Applicant
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Correspondent
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Regulation Number878.4800
Classification Product Code
GDX  
Date Received03/17/1982
Decision Date 04/09/1982
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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