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 K023757
Device Name CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
Applicant
ENDOCARE, INC.
201 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
ENDOCARE, INC.
201 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact EBEN GORDON
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received11/08/2002
Decision Date 12/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-