Device Classification Name |
Hood, Oxygen, Infant
|
510(k) Number |
K973128 |
Device Name |
OLYMPUS NA-10J-1 ASPIRATION NEEDLE |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
SUBHASH R PATEL |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
SUBHASH R PATEL |
Regulation Number | 868.5700
|
Classification Product Code |
|
Date Received | 08/21/1997 |
Decision Date | 11/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|