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 K946019
Device Name SURGICLA INSTRUMENT KIT
Applicant
Medical Action Industries, Inc.
537 Sweeten Ck. Industrial Pk.
Asheville,  NC  28803
Applicant Contact STEVE WOODY
Correspondent
Medical Action Industries, Inc.
537 Sweeten Ck. Industrial Pk.
Asheville,  NC  28803
Correspondent Contact STEVE WOODY
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/12/1994
Decision Date 03/20/1995
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
-
-