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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 K912882
Device Name INNERVISION LAPAROSCOPE AND ACCESSORIES
Applicant
M.D. ENGINEERING, INC.
2536 BARRINGTON COURT
HAYWARD,  CA  94545
Applicant Contact ANDREW HALSEY
Correspondent
M.D. ENGINEERING, INC.
2536 BARRINGTON COURT
HAYWARD,  CA  94545
Correspondent Contact ANDREW HALSEY
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/01/1991
Decision Date 01/24/1992
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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