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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 K931220
Device Name SPERMICIDAL LUBRICATED CONDOM
Applicant
Monsys USA, Inc.
116 N. Main St.
Philippi,  WV  26416
Applicant Contact FRANK FINOCCHIARO
Correspondent
Monsys USA, Inc.
116 N. Main St.
Philippi,  WV  26416
Correspondent Contact FRANK FINOCCHIARO
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received03/10/1993
Decision Date 05/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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