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 K882009
Device Name KING KONDOM (CONDOM)
Applicant
KING KONDOM PRODUCTS, INC.
301 - 2245 WEST BROADWAY
VANCOUVER, B.C.
CANADA,  CA V6K 2E4
Applicant Contact PHILIP M SNELL
Correspondent
KING KONDOM PRODUCTS, INC.
301 - 2245 WEST BROADWAY
VANCOUVER, B.C.
CANADA,  CA V6K 2E4
Correspondent Contact PHILIP M SNELL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/13/1988
Decision Date 09/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-