Device Classification Name |
General Surgery Tray
|
510(k) Number |
K964011 |
Device Name |
SUCTION CATHETER TRAY PRODUCT NO. 900277 |
Applicant |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Applicant Contact |
OSVALDO RODRIGUEZ |
Correspondent |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Correspondent Contact |
OSVALDO RODRIGUEZ |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 10/07/1996 |
Decision Date | 11/25/1996 |
Decision |
Substantially Equivalent - Kit
(SESK) |
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
|