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

Name: FDA 510(k) clearance K133857
Creator: U.S. Food and Drug Administration
Published: 2014-04-28

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.. Device class: 2.

Clearance details

Applicant: Proa Medical, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
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

Download summary PDF View on FDA.gov ↗

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