Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K091087 |
Device Name |
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
Applicant |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
JENNIFER BRENNAN |
Correspondent |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
JENNIFER BRENNAN |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 04/15/2009 |
Decision Date | 04/22/2009 |
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
|