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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 K982673
Device Name JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
Applicant
Key West Fragrance & Cosmetic
19526 E. Lake Dr.
Miami,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
Key West Fragrance & Cosmetic
19526 E. Lake Dr.
Miami,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/31/1998
Decision Date 10/29/1998
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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