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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 K831816
Device Name PROTEX CONTRACEPT PLUS W/SPERM-LUB
Applicant
National Sanitary Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
National Sanitary Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/06/1983
Decision Date 09/12/1983
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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