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 K880463
Device Name CONDOM (PROPHYLACTIC)
Applicant
HEALTH TECHNOLOGIES INTL.
200 WEST MERCER STE.307
SEATTLE,  WA  98119
Applicant Contact HELEN I MARIESKIND
Correspondent
HEALTH TECHNOLOGIES INTL.
200 WEST MERCER STE.307
SEATTLE,  WA  98119
Correspondent Contact HELEN I MARIESKIND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/03/1988
Decision Date 06/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-