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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 K913242
Device Name MICROPROCESSED CONTROLLED LAPAROFLATOR
Applicant
BRYAN CORP.
FOUR PLYMPTON ST.
WOBURN,  MA  01801
Applicant Contact FRANK M ABRANO
Correspondent
BRYAN CORP.
FOUR PLYMPTON ST.
WOBURN,  MA  01801
Correspondent Contact FRANK M ABRANO
Regulation Number884.1730
Classification Product Code
HIF  
Date Received07/22/1991
Decision Date 09/25/1992
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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