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 unit, cryosurgical, accessories
510(k) Number K024009
Device Name CRYOPROBE
Applicant
H&O EQUIPMENTS NV/SA
4655 KIRKWOOD CT.
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
H&O EQUIPMENTS NV/SA
4655 KIRKWOOD CT.
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/04/2002
Decision Date 03/20/2003
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
-
-