Device Classification Name |
Arthroscope
|
510(k) Number |
K191345 |
Device Name |
Pegasus System |
Applicant |
A.M. Surgical, Inc. |
285 Middle Country Road, Suite 206 |
Smithtown,
NY
11787
|
|
Applicant Contact |
Vincent Pascale |
Correspondent |
A.M. Surgical, Inc. |
285 Middle Country Road, Suite 206 |
Smithtown,
NY
11787
|
|
Correspondent Contact |
Vincent Pascale |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 05/20/2019 |
Decision Date | 07/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|