Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K170810 |
Device Name |
CRYOFOS |
Applicant |
CRYOFOS Medical Gmbh |
Lammstrasse 21 |
Karlsruhe,
DE
76133
|
|
Applicant Contact |
Gerlinde Hornung-Stehling |
Correspondent |
Tenssource LLC |
724 Bald Cypress Place |
Tampa,
FL
33614
|
|
Correspondent Contact |
Nick Stocks |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/17/2017 |
Decision Date | 09/27/2017 |
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
|