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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 K852141
Device Name STERILE SURGICAL BLADES
Applicant
Miltex Instrument Co.
6 Ohio Dr.
Lake Success,  NY  11042
Applicant Contact KLEIN KRAMER
Correspondent
Miltex Instrument Co.
6 Ohio Dr.
Lake Success,  NY  11042
Correspondent Contact KLEIN KRAMER
Regulation Number878.4800
Classification Product Code
GES  
Date Received05/16/1985
Decision Date 06/13/1985
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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