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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 K213783
Device Name Apyx
Applicant
Escala Medical
17th Tchelet Street
Misgav Industrial Park,  IL 2017400
Applicant Contact Edit Goldberg
Correspondent
Hogan Lovells
555 Thirteenth Street, NW
Washington,  DC  20004 -1109
Correspondent Contact Jonathan Kahan
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received12/03/2021
Decision Date 04/05/2022
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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