Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K180211 |
Device Name |
Freezpoint |
Applicant |
Bovie Medical Corp. |
5115 Ulmerton Road |
Clearwater,
FL
33760
|
|
Applicant Contact |
Sam Niedbala |
Correspondent |
CryoConcepts LP |
205 Webster Street |
Bethlehem,
PA
18015
|
|
Correspondent Contact |
Sam Niedbala |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 01/25/2018 |
Decision Date | 03/21/2018 |
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
|