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 Wrap, Sterilization
510(k) Number K850289
Device Name MONARCH STERILIZATION CONTAINER SYSTEM
Applicant
Monarch Products, Inc.
P.O. Box 1899
Jacksonville,  TX  75766
Applicant Contact RODNEY D CONSTANT
Correspondent
Monarch Products, Inc.
P.O. Box 1899
Jacksonville,  TX  75766
Correspondent Contact RODNEY D CONSTANT
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/24/1985
Decision Date 08/15/1985
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
-
-