The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet, Model Fp6t5, Fp5t5, Fp5t3.
Device ID | K011950 |
510k Number | K011950 |
Device Name: | SEEDNET, MODEL FP6T5, FP5T5, FP5T3 |
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 | 2001-06-21 |
Decision Date | 2002-01-29 |
Summary: | summary |