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 Sterilizer, Ethylene-Oxide Gas
510(k) Number K920930
Device Name MDT/CASTLE 10/90 DUAL LOAD STATION
Applicant
MDT CORP., INC.
1777 EAST HENRIETTA RD.(14623)
P.O. BOX 23077
ROCHESTER,  NY  14692
Applicant Contact MARK N SMITH
Correspondent
MDT CORP., INC.
1777 EAST HENRIETTA RD.(14623)
P.O. BOX 23077
ROCHESTER,  NY  14692
Correspondent Contact MARK N SMITH
Regulation Number880.6860
Classification Product Code
FLF  
Date Received02/28/1992
Decision Date 03/31/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-