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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K943100
Device Name STRYKER OPERATING LAPAROSCOPE
Applicant
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Applicant Contact LARRY VOSS
Correspondent
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Correspondent Contact LARRY VOSS
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/29/1994
Decision Date 08/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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