Device Classification Name |
Arthroscope
|
510(k) Number |
K060198 |
Device Name |
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
ELIZABETH PAUL |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
ELIZABETH PAUL |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 01/26/2006 |
Decision Date | 05/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|