Device Classification Name |
kit, surgical instrument, disposable
|
510(k) Number |
K870373 |
Device Name |
STERILE PROCEDURAL TRAYS |
Applicant |
DIMED, INTL. |
3108 BRUTON RD. |
PLANT CITY,
FL
33566
|
|
Applicant Contact |
CHUCK MASEK |
Correspondent |
DIMED, INTL. |
3108 BRUTON RD. |
PLANT CITY,
FL
33566
|
|
Correspondent Contact |
CHUCK MASEK |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/29/1987 |
Decision Date | 03/20/1987 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|