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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K991047
Device Name HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
Applicant
Hardcover Products, Inc.
55 Administration Rd., Unit 12
Concord, Ontario,  CA L4K 4G9
Applicant Contact GERRY PERSON
Correspondent
Hardcover Products, Inc.
55 Administration Rd., Unit 12
Concord, Ontario,  CA L4K 4G9
Correspondent Contact GERRY PERSON
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received03/30/1999
Decision Date 06/18/1999
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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