Device Classification Name |
staple, implantable
|
510(k) Number |
K063746 |
Device Name |
POWER EXTENDERS MODEL# PEC200, PES200,PES200S |
Applicant |
POWER MEDICAL INTERVENTIONS, INC. |
2021 CABOT BLVD. |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
BARBARA WHITMAN |
Correspondent |
POWER MEDICAL INTERVENTIONS, INC. |
2021 CABOT BLVD. |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
BARBARA WHITMAN |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 12/18/2006 |
Decision Date | 01/12/2007 |
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
|
|
|