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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Surgical, General & Plastic Surgery
510(k) Number K922659
Device Name GENERAL SURGERY CLAMP AND NEEDLE HOLDER
Applicant
Miltex Instrument Co.
6 Ohio Dr.
Lake Success,  NY  11042
Applicant Contact ROBERT B PUGLIESI
Correspondent
Miltex Instrument Co.
6 Ohio Dr.
Lake Success,  NY  11042
Correspondent Contact ROBERT B PUGLIESI
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received06/03/1992
Decision Date 07/21/1992
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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