Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name condom
510(k) Number K982673
Device Name JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
Applicant
KEY WEST FRAGRANCE & COSMETIC
19526 EAST LAKE DR.
MIAMI,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
KEY WEST FRAGRANCE & COSMETIC
19526 EAST 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
-
-