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 cannula, intrauterine insemination
510(k) Number K972245
Device Name TOM CAT F.L., TOM CAT S.L.
Applicant
A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA,  GA  30201
Correspondent
A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA,  GA  30201
Regulation Number884.5250
Classification Product Code
MFD  
Date Received06/16/1997
Decision Date 08/06/1997
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
-
-