Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K930632 |
Device Name |
CHEMOSITE IMPLANTABLE DRUG DELIVERY |
Applicant |
DEVICE LABS, INC. |
3 INDUSTRIAL PARK RD. |
MEDWAY,
MA
02053
|
|
Applicant Contact |
ELTON M TUCKER |
Correspondent |
DEVICE LABS, INC. |
3 INDUSTRIAL PARK RD. |
MEDWAY,
MA
02053
|
|
Correspondent Contact |
ELTON M TUCKER |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 02/08/1993 |
Decision Date | 12/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|