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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, scented, deodorized
510(k) Number K950928
Device Name ULTIMATES SILK GLIDE TAMPONS
Applicant
PLAYTIME PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Applicant Contact IRWIN BUTENSKY
Correspondent
PLAYTIME PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5460
Classification Product Code
HIL  
Subsequent Product Code
HEB  
Date Received03/01/1995
Decision Date 03/22/1995
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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