Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K014253 |
Device Name |
DERMACHILLER 4 |
Applicant |
PARADIGM TREX, LLC |
10455 PACIFIC CENTER CT. |
SAN DIEGO,
CA
92121 -4339
|
|
Applicant Contact |
NIKOLAI TANKOVICH |
Correspondent |
PARADIGM TREX, LLC |
10455 PACIFIC CENTER CT. |
SAN DIEGO,
CA
92121 -4339
|
|
Correspondent Contact |
NIKOLAI TANKOVICH |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/26/2001 |
Decision Date | 03/26/2002 |
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
|