• 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 K897129
Device Name CONDOMS (MULTIPLE BRANDS)
Applicant
SAGAMI, INC.
8725 WEST HIGGINS RD.
SUITE 481
chicago,  IL  60631
Applicant Contact tim weaver
Correspondent
SAGAMI, INC.
8725 WEST HIGGINS RD.
SUITE 481
chicago,  IL  60631
Correspondent Contact tim weaver
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/26/1989
Decision Date 05/16/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-