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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, Scented-Deodorized
510(k) Number K841155
Device Name DEODORANT SLENDER REG. TAMPONS
Applicant
Playtex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Playtex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.5460
Classification Product Code
HIL  
Date Received03/19/1984
Decision Date 03/19/1984
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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