Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K951870 |
Device Name |
MORELL INJECTOR |
Applicant |
INCUTECH, INC. |
307-A SOUTH WESTGATE DR. |
GREENSBORO,
NC
27407
|
|
Applicant Contact |
ROGER V MOLINA |
Correspondent |
INCUTECH, INC. |
307-A SOUTH WESTGATE DR. |
GREENSBORO,
NC
27407
|
|
Correspondent Contact |
ROGER V MOLINA |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 04/21/1995 |
Decision Date | 01/22/1996 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|