Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K992537 |
Device Name |
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED |
Applicant |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Applicant Contact |
MARY KAY KESSINGER SOBCINSKI |
Correspondent |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Correspondent Contact |
MARY KAY KESSINGER SOBCINSKI |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/29/1999 |
Decision Date | 02/22/2000 |
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
|