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 Cap, Cervical
510(k) Number K945131
Device Name IMAGYN INTRAUTERINE INSEMINATION DEVICE
Applicant
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Applicant Contact DEBRA A RINDERER
Correspondent
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Correspondent Contact DEBRA A RINDERER
Regulation Number884.5250
Classification Product Code
HDR  
Date Received10/19/1994
Decision Date 05/15/1995
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
-
-