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 K982628
Device Name MEDWORKS INSEMINATION CATHETER
Applicant
MEDWORKS CORP.
50 BREWSTER ST.
PAWTUCKET,  RI  02860
Applicant Contact PAMELA PAPINEAU
Correspondent
MEDWORKS CORP.
50 BREWSTER ST.
PAWTUCKET,  RI  02860
Correspondent Contact PAMELA PAPINEAU
Regulation Number884.5250
Classification Product Code
MFD  
Date Received07/28/1998
Decision Date 08/21/1998
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
-
-