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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 K001978
Device Name 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
Applicant
Thai Nippon Rubber Industry Co., Ltd.
1219 Little Creek Rd.
Durham,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
Thai Nippon Rubber Industry Co., Ltd.
1219 Little Creek Rd.
Durham,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received06/29/2000
Decision Date 08/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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