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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 K160569
Device Name NeuGuide
Applicant
POP Medical Solutions
27 Habarzel ST.
Tel Aviv,  IL 6971039
Applicant Contact Guy Ohad
Correspondent
POP Medical Solutions
27 Habarzel ST.
Tel Aviv,  IL 6971039
Correspondent Contact Paul Dryden
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received02/29/2016
Decision Date 07/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02190825
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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