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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 K982276
Device Name BAHO AUTOCLAVABLE LAPAROSCOPE
Applicant
MICROPTIX INT'L, LLC.
310 MAIN ST., SUITE LL-D
EAST HAVEN,  CT  06512
Applicant Contact GEORGE N HALLACK
Correspondent
MICROPTIX INT'L, LLC.
310 MAIN ST., SUITE LL-D
EAST HAVEN,  CT  06512
Correspondent Contact GEORGE N HALLACK
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/29/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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