Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K102639 |
Device Name |
SL3 |
Applicant |
DISCUS DENTAL, LLC |
8550 HIGUERA ST. |
CULVER CITY,
CA
90232
|
|
Applicant Contact |
CLARK D VONAHSEN |
Correspondent |
DISCUS DENTAL, LLC |
8550 HIGUERA ST. |
CULVER CITY,
CA
90232
|
|
Correspondent Contact |
CLARK D VONAHSEN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/14/2010 |
Decision Date | 12/01/2010 |
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
|
Recalls |
CDRH Recalls
|