CRYO-HIT
Unit, Cryosurgical, Accessories
GALIL MEDICAL LTD.
The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Cryo-hit.
Pre-market Notification Details
| Device ID | K993965 |
| 510k Number | K993965 |
| Device Name: | CRYO-HIT |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-23 |
| Decision Date | 2000-02-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830891 | K993965 | 000 |
Trademark Results [CRYO-HIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYO-HIT 75287280 2316977 Live/Registered |
GALIL MEDICAL LTD. 1997-05-05 |
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