SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K051052
Device Name SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
Applicant
GALIL MEDICAL LTD.
555 thirteenth street, n.w.
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
GALIL MEDICAL LTD.
555 thirteenth street, n.w.
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received 04/25/2005
Decision Date 05/06/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls