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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetrical, Manual (And Accessories)
510(k) Number K963505
Device Name TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
Applicant
Tenet Medical Engineering
3553 31st St., NW
Calgary,  CA T2L 2K7
Applicant Contact KEN MOORE
Correspondent
Tenet Medical Engineering
3553 31st St., NW
Calgary,  CA T2L 2K7
Correspondent Contact KEN MOORE
Regulation Number884.4900
Classification Product Code
HHP  
Date Received09/03/1996
Decision Date 02/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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