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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K823475
Device Name BROOKS SCLEROTHERAPY CUFF
Applicant
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Applicant Contact FLO BECKER
Correspondent
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Correspondent Contact FLO BECKER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/22/1982
Decision Date 07/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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