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 Decontamination Kit
510(k) Number K894455
Device Name DECONTAMINATING KIT, SKIN: M291
Applicant
Dept. of the Army
Mater Devel Activity Sgrd-Ump
Fort Detrick
Frederick,  MD  21701
Applicant Contact RONALD E CLAWSON
Correspondent
Dept. of the Army
Mater Devel Activity Sgrd-Ump
Fort Detrick
Frederick,  MD  21701
Correspondent Contact RONALD E CLAWSON
Regulation Number878.4014
Classification Product Code
MAC  
Date Received07/25/1989
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-