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 Gauze / Sponge,Nonresorbable For External Use
510(k) Number K923846
Device Name BURN DRESSING
Applicant
Medical Action Industries, Inc.
1934 New Hwy.
Farmingdale,  NY  11735
Applicant Contact STEPHEN T WOODY
Correspondent
Medical Action Industries, Inc.
1934 New Hwy.
Farmingdale,  NY  11735
Correspondent Contact STEPHEN T WOODY
Regulation Number878.4014
Classification Product Code
NAB  
Date Received07/31/1992
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-