• 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 K923612
Device Name MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
houston,  TX  77236 -6221
Applicant Contact gary j sfeir
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
houston,  TX  77236 -6221
Correspondent Contact gary j sfeir
Regulation Number884.5250
Classification Product Code
MFD  
Date Received07/21/1992
Decision Date 09/07/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-