Device Classification Name |
Tray, Surgical, Instrument
|
510(k) Number |
K971217 |
Device Name |
INSTRUMENT TRAY LINER |
Applicant |
GENERAL HOSPITAL SUPPLY CORP. |
196 DANBURY RD. |
WILTON,
CT
06897
|
|
Applicant Contact |
PHILLIP DAVIS |
Correspondent |
GENERAL HOSPITAL SUPPLY CORP. |
196 DANBURY RD. |
WILTON,
CT
06897
|
|
Correspondent Contact |
PHILLIP DAVIS |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/02/1997 |
Decision Date | 05/06/1997 |
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
|