Device Classification Name |
Electrode, Electrosurgical
|
510(k) Number |
K952323 |
Device Name |
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES |
Applicant |
MIST, INC. |
55 NORTHERN BLVD. |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
CAROLANN KOTULA |
Correspondent |
MIST, INC. |
55 NORTHERN BLVD. |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
CAROLANN KOTULA |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/18/1995 |
Decision Date | 06/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|