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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 K932689
Device Name LAPRO-LOADER(TM)
Applicant
SURGIMARK, INC.
4706 WEST NOB HILL BLVD.
YAKIMA,  WA  98908
Applicant Contact RICHARD YARGER
Correspondent
SURGIMARK, INC.
4706 WEST NOB HILL BLVD.
YAKIMA,  WA  98908
Correspondent Contact RICHARD YARGER
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/03/1993
Decision Date 04/11/1994
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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