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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 K893033
Device Name MINI-DIAMOND KNIFE
Applicant
L.A.B. Instruments
1802 N. Carson St.
Suite 146
Carson City,  NV  89701
Applicant Contact WILLIAM BALLARD
Correspondent
L.A.B. Instruments
1802 N. Carson St.
Suite 146
Carson City,  NV  89701
Correspondent Contact WILLIAM BALLARD
Regulation Number878.4800
Classification Product Code
GDX  
Date Received04/24/1989
Decision Date 05/26/1989
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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