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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insufflator, laparoscopic
510(k) Number K920959
Device Name INSUFFLATOR, LAPAROSCOPIC
Applicant
MECTRA LABS, INC.
HIGHWAY 231 SOUTH,
2 QUALITY WAY
BLOOMFIELD,  IN  47424
Applicant Contact ELIZABETH FELDMAN
Correspondent
MECTRA LABS, INC.
HIGHWAY 231 SOUTH,
2 QUALITY WAY
BLOOMFIELD,  IN  47424
Correspondent Contact ELIZABETH FELDMAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/25/1992
Decision Date 07/13/1992
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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