BRELLA-SPEC(TM) VAGINAL SPECULUM— 510(k) K133857

Substantially Equivalent

Proa Medical, Inc.

FDA 510(k) clearance K133857 for BRELLA-SPEC(TM) VAGINAL SPECULUM, Substantially Equivalent on 2014-04-28. Applicant: Proa Medical, Inc..

Clearance details

Applicant: Proa Medical, Inc.
Product code: Code HIB
Advisory panel: Obstetrics/Gynecology
Date received: 2013-12-19
Decision date: 2014-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redondo Beach, CA, US

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