• 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 microscope, surgical, general & plastic surgery
510(k) Number K910357
Device Name SOM 6V
Applicant
JEDMED INSTRUMENT CO.
6069 LEMAY FERRY RD.
ST. LOUIS,  MO  63129
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
6069 LEMAY FERRY RD.
ST. LOUIS,  MO  63129
Correspondent Contact CRAIG RAPP
Regulation Number878.4700
Classification Product Code
FSO  
Date Received01/29/1991
Decision Date 02/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-