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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K133857
Device Name BRELLA-SPEC(TM) VAGINAL SPECULUM
Applicant
Proa Medical, Inc.
2512 Artesia Blvd. Suite 305c
Redondo Beach,  CA  90278
Applicant Contact VICTORIA NADERSHAHI
Correspondent
Proa Medical, Inc.
2512 Artesia Blvd. Suite 305c
Redondo Beach,  CA  90278
Correspondent Contact VICTORIA NADERSHAHI
Regulation Number884.4530
Classification Product Code
HIB  
Date Received12/19/2013
Decision Date 04/28/2014
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
Predetermined Change
Control Plan Authorized		 No
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