CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K991272
Device Name CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E
Applicant
GALIL MEDICAL LTD.
555 thirteenth street, n.w.
washington, 
DC 
20004

Applicant Contact howard m holstein
Correspondent
GALIL MEDICAL LTD.
555 thirteenth street, n.w.
washington, 
DC 
20004

Correspodent Contact howard m holstein
Regulation Number 878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received 04/13/1999
Decision Date 07/12/1999
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