Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K203032 |
Device Name |
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle |
Applicant |
Galil Medical Inc. |
4634 Round Lake Rd W |
Arden Hills,
MN
55112
|
|
Applicant Contact |
Amy McKinney |
Correspondent |
Galil Medical Inc. |
4634 Round Lake Rd W |
Arden Hills,
MN
55112
|
|
Correspondent Contact |
Amy McKinney |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 10/05/2020 |
Decision Date | 11/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|