Device Classification Name |
Splint, Extremity, Inflatable, External
|
510(k) Number |
K874050 |
Device Name |
INFLATABLE FOOT & ANKLE SPLINT |
Applicant |
VINYL TECHNOLOGY, INC. |
2110 EDWARDS AVE. |
SO. EL MONTE,
CA
91733
|
|
Applicant Contact |
CARLOS A MOLLURA |
Correspondent |
VINYL TECHNOLOGY, INC. |
2110 EDWARDS AVE. |
SO. EL MONTE,
CA
91733
|
|
Correspondent Contact |
CARLOS A MOLLURA |
Regulation Number | 878.3900
|
Classification Product Code |
|
Date Received | 10/05/1987 |
Decision Date | 11/23/1987 |
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
|
|
|