The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet/seednetgold, Cryothera And Cryo-hit Systems.
Device ID | K060144 |
510k Number | K060144 |
Device Name: | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-19 |
Decision Date | 2006-02-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290104830242 | K060144 | 000 |
07290104830235 | K060144 | 000 |