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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, surgical, floor standing
510(k) Number K961971
Device Name Q-5000
Stryker Endoscopy
2590 walsh ave.
santa clara,  CA  95051 -4085
Applicant Contact bader-e bellahsene, ph.d.
Stryker Endoscopy
2590 walsh ave.
santa clara,  CA  95051 -4085
Correspondent Contact bader-e bellahsene, ph.d.
Regulation Number878.4580
Classification Product Code
Subsequent Product Code
Date Received05/20/1996
Decision Date 06/28/1996
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