Device Classification Name |
Staple, Implantable
|
510(k) Number |
K190331 |
Device Name |
Applied Medical Laparoscopic Linear Cutter |
Applicant |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Aditi Iyengar |
Correspondent |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Aditi Iyengar |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/14/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|