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 K010991
Device Name SEEDNET, MODELS FP6T5, FP5T5, FP5T3
Applicant
GALIL MEDICAL LTD.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JOHATHAN S KAHAN
Correspondent
GALIL MEDICAL LTD.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JOHATHAN S KAHAN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/03/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-