Device Classification Name |
Guide, Needle, Surgical
|
510(k) Number |
K935457 |
Device Name |
LOCALIZATION WIRE OR MARKER - SURGICAL |
Applicant |
BIP USA, INC. |
CARBORUNDUM CENTER |
SUITE 480, 345 THIRD STREET |
NIAGARA FALLS,
NY
14303
|
|
Applicant Contact |
GARY HORNER |
Correspondent |
BIP USA, INC. |
CARBORUNDUM CENTER |
SUITE 480, 345 THIRD STREET |
NIAGARA FALLS,
NY
14303
|
|
Correspondent Contact |
GARY HORNER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/12/1993 |
Decision Date | 02/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|