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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 K990925
Device Name MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
Applicant
Hardcover Products, Inc.
55 Administration Rd., Unit 12
Concord, Ontario,  CA L4K 4G9
Applicant Contact GERRY GLAZER
Correspondent
Hardcover Products, Inc.
55 Administration Rd., Unit 12
Concord, Ontario,  CA L4K 4G9
Correspondent Contact GERRY GLAZER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/19/1999
Decision Date 06/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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