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 dilator, cervical, fixed size
510(k) Number K890377
Device Name FIXED-SIZE UTERINE DILATOR
Applicant
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number884.4530
Classification Product Code
HDQ  
Date Received01/23/1989
Decision Date 02/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-