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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 K874464
Device Name SPERMICIDAL CONDOM
Applicant
ROYAL AMERICAN INDUSTRIES, INC.
10309 SILVER LAKE DR.
BOCA RATON,  FL  33428
Applicant Contact IRWIN VOLIN
Correspondent
ROYAL AMERICAN INDUSTRIES, INC.
10309 SILVER LAKE DR.
BOCA RATON,  FL  33428
Correspondent Contact IRWIN VOLIN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/26/1987
Decision Date 11/20/1987
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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