Device Classification Name |
clip, implantable
|
510(k) Number |
K991002 |
Device Name |
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP |
Applicant |
V. MUELLER NEURO/SPINE |
360 INDUSTRIAL RD., UNIT H |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
TERRY JOHNSTON |
Correspondent |
V. MUELLER NEURO/SPINE |
360 INDUSTRIAL RD., UNIT H |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
TERRY JOHNSTON |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 03/25/1999 |
Decision Date | 06/11/1999 |
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
|
|
|