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 Kit, Surgical Instrument, Disposable
510(k) Number K803117
Device Name CUSTOM DRESSING TRAY WET TO DRY
Applicant
American Medical Disposable, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Medical Disposable, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
KDD  
Date Received12/10/1980
Decision Date 12/23/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-