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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 K952394
Device Name PLAYTEX TAMPONS #13695
Applicant
PLAYTIME PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Applicant Contact MARK ROSENGARTEN
Correspondent
PLAYTIME PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Correspondent Contact MARK ROSENGARTEN
Regulation Number884.5470
Classification Product Code
HEB  
Subsequent Product Code
HIL  
Date Received05/22/1995
Decision Date 08/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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