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 Coil, Magnetic Resonance, Specialty
510(k) Number K964141
Device Name GE STERILE DISPOSABLE EQUIPMENT COIL COVER
Applicant
Contour Fabricators, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Applicant Contact EDWARD H RANSOM
Correspondent
Contour Fabricators, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Correspondent Contact EDWARD H RANSOM
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/15/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-