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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K884692
Device Name THE SAFEGARD PERSONAL PROTECTION KIT
Applicant
THE SAFEGARD PROTECTION CORP.
P.O. BOX 2474
WAILUKU,  HI  96793
Applicant Contact PRATIBHA EASTWOOD
Correspondent
THE SAFEGARD PROTECTION CORP.
P.O. BOX 2474
WAILUKU,  HI  96793
Correspondent Contact PRATIBHA EASTWOOD
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/09/1988
Decision Date 09/12/1989
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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