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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tampon, Menstrual, Unscented
510(k) Number K140077
Device Name ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
Applicant
ALBAAD LTD.
30 NECK ROAD
OLD LYME,  CT  06371
Applicant Contact ROBERT J STAAB, PH.D.
Correspondent
ALBAAD LTD.
30 NECK ROAD
OLD LYME,  CT  06371
Correspondent Contact ROBERT J STAAB, PH.D.
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/13/2014
Decision Date 09/22/2014
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
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