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 colposcope (and colpomicroscope)
510(k) Number K890387
Device Name MALLEABLE PLACENTA CURETTE
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 Number884.1630
Classification Product Code
HEX  
Date Received01/23/1989
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-