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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 K934094
Device Name STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Applicant
STRYKER CORP.
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Applicant Contact CHARLES NELSON
Correspondent
STRYKER CORP.
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Correspondent Contact CHARLES NELSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/23/1993
Decision Date 02/18/1994
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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