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 K954099
Device Name SELECT IUI
Applicant
Select Medical Systems, Inc.
2 Wintersport Ln.
Williston,  VT  05495
Applicant Contact MONIQUE GIRARD
Correspondent
Select Medical Systems, Inc.
2 Wintersport Ln.
Williston,  VT  05495
Correspondent Contact MONIQUE GIRARD
Regulation Number884.5250
Classification Product Code
MFD  
Date Received08/31/1995
Decision Date 11/22/1995
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
-
-