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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 K942447
Device Name HASSON OPEN LAPAROSCOPY CANNULA
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Applicant Contact CAROL A WEIDEMAN
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Correspondent Contact CAROL A WEIDEMAN
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/23/1994
Decision Date 12/15/1994
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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