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, Synthetic
510(k) Number K922688
FOIA Releasable 510(k) K922688
Device Name EXTRA PROTECTION POLYURETHANE CONDOM
Applicant
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Applicant Contact ALICE A DEPAUL
Correspondent
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Correspondent Contact ALICE A DEPAUL
Regulation Number884.5300
Classification Product Code
MOL  
Date Received06/04/1992
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-