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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, menstrual, unscented
510(k) Number K900421
Device Name PROMISE ABSORBENT PROTECTIVE PAD
Original Applicant
SCOTT HEALTH CARE
scott plaza iii
philadelphia,  PA  19113 1585
Original Contact richard a hamer
Regulation Number884.5435
Classification Product Code
HHD  
Date Received01/30/1990
Decision Date 06/06/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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