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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 K874236
Device Name APOLLO CONDOM
Applicant
Apollo Enterprise, Ltd. Co.
1395 NW 167 St., Suite 103
Miami,  FL  33169
Applicant Contact HOWARD DOLLINGER,DDS
Correspondent
Apollo Enterprise, Ltd. Co.
1395 NW 167 St., Suite 103
Miami,  FL  33169
Correspondent Contact HOWARD DOLLINGER,DDS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/15/1987
Decision Date 07/01/1988
Decision Substantially Equivalent (SESE)
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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