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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K903208
Device Name MAXI-FLOW INSUFFLATOR TUBING SET
Applicant
ADLER INSTRUMENT CO.
6191 ATLANTIC BLVD.
NORCROSS,  GA  30071
Applicant Contact NORMAN BLACK
Correspondent
ADLER INSTRUMENT CO.
6191 ATLANTIC BLVD.
NORCROSS,  GA  30071
Correspondent Contact NORMAN BLACK
Regulation Number884.1300
Classification Product Code
HES  
Date Received07/20/1990
Decision Date 12/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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