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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 K993794
Device Name PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
Applicant
PLAYTIME PRODUCTS, INC.
TECHNICAL CENTER
75 COMMERCE DRIVE
ALLENDALE,  NJ  07401 -1600
Applicant Contact MARK ROSENGARTEN
Correspondent
PLAYTIME PRODUCTS, INC.
TECHNICAL CENTER
75 COMMERCE DRIVE
ALLENDALE,  NJ  07401 -1600
Correspondent Contact MARK ROSENGARTEN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/09/1999
Decision Date 02/07/2000
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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