Device Classification Name |
staple, implantable
|
510(k) Number |
K111064 |
Device Name |
TIGERPAW SYSTEM II |
Applicant |
LAAX, INC. |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Applicant Contact |
MICHAEL A DANIEL |
Correspondent |
LAAX, INC. |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Correspondent Contact |
MICHAEL A DANIEL |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/2011 |
Decision Date | 05/18/2011 |
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
|
|
|