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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fixation, non-absorbable or absorbable, for pelvic use
510(k) Number K130059
Device Name ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
Applicant
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
1914 J.N. PEASE PLACE
CHARLOTTE,  NC  28262
Applicant Contact ELISSA BURG
Correspondent
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
1914 J.N. PEASE PLACE
CHARLOTTE,  NC  28262
Correspondent Contact ELISSA BURG
Regulation Number884.4530
Classification Product Code
PBQ  
Subsequent Product Code
OTO  
Date Received01/10/2013
Decision Date 07/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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