Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K091061 |
Device Name |
IMPLICITGUIDE SURGICAL SUTURE SYSTEM |
Applicant |
IMPLICITCARE, LLC |
13221 MARICOTTE PLACE |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
IMPLICITCARE, LLC |
13221 MARICOTTE PLACE |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
STEVE REITZLER |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 04/14/2009 |
Decision Date | 11/13/2009 |
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
|
|
|