Device Classification Name |
clamp, surgical, general & plastic surgery
|
510(k) Number |
K922659 |
Device Name |
GENERAL SURGERY CLAMP AND NEEDLE HOLDER |
Applicant |
MILTEX INSTRUMENT CO. |
6 OHIO DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
ROBERT B PUGLIESI |
Correspondent |
MILTEX INSTRUMENT CO. |
6 OHIO DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
ROBERT B PUGLIESI |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/03/1992 |
Decision Date | 07/21/1992 |
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
|