• 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 Device, Surgical, Cryogenic
510(k) Number K050272
Device Name CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
Applicant
CRYOMEDICAL INSTRUMENTS, LTD.
GROVE WAY
MANSFIELD WOODHOUSE
MANSFIELD,  GB NG19 8BW
Applicant Contact GARETH COPPING
Correspondent
CRYOMEDICAL INSTRUMENTS, LTD.
GROVE WAY
MANSFIELD WOODHOUSE
MANSFIELD,  GB NG19 8BW
Correspondent Contact GARETH COPPING
Regulation Number882.4250
Classification Product Code
GXH  
Date Received02/04/2005
Decision Date 03/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-