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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K935709
Device Name GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS
Applicant
ZIMMER PATIENT CARE DIVISION
200 WEST OHIO AVE.
P.O.BOX 10
DOVER,  OH  44622
Applicant Contact PAULA S OSORIO
Correspondent
ZIMMER PATIENT CARE DIVISION
200 WEST OHIO AVE.
P.O.BOX 10
DOVER,  OH  44622
Correspondent Contact PAULA S OSORIO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/30/1993
Decision Date 01/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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