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 General Surgery Tray
510(k) Number K890570
Device Name SKIN SCRUB KIT
Applicant
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Applicant Contact THOMAS J SANDERS
Correspondent
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Correspondent Contact THOMAS J SANDERS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received02/06/1989
Decision Date 05/05/1989
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
Predetermined Change
Control Plan Authorized		 No
-
-