Device Classification Name |
i.v. start kit
|
510(k) Number |
K951167 |
Device Name |
EMS I.V. START KIT |
Applicant |
EMERGENCY MEDICAL SUPPLY, INC. |
P.O. BOX 99 |
SHEPHERDSVILLE,
KY
40165
|
|
Applicant Contact |
WILLIAM MARTIN JR. |
Correspondent |
EMERGENCY MEDICAL SUPPLY, INC. |
P.O. BOX 99 |
SHEPHERDSVILLE,
KY
40165
|
|
Correspondent Contact |
WILLIAM MARTIN JR. |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/14/1995 |
Decision Date | 05/16/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|