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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K974066
Device Name RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
Applicant
Microline Pentax, Inc.
181 Elliot St.
Suite 915
Beverly,  MA  01915
Applicant Contact HUGHES DE LAFORCADE
Correspondent
Microline Pentax, Inc.
181 Elliot St.
Suite 915
Beverly,  MA  01915
Correspondent Contact HUGHES DE LAFORCADE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/27/1997
Decision Date 01/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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