Device Classification Name |
Mouthpiece, Breathing
|
510(k) Number |
K853402 |
Device Name |
E-Z-GUARD MOUTHPIECE |
Applicant |
E-Z-EM, INC. |
717 MAIN ST. |
WESTBURY,
NY
11590
|
|
Applicant Contact |
JACK T BERGER |
Correspondent |
E-Z-EM, INC. |
717 MAIN ST. |
WESTBURY,
NY
11590
|
|
Correspondent Contact |
JACK T BERGER |
Regulation Number | 868.5620
|
Classification Product Code |
|
Date Received | 08/12/1985 |
Decision Date | 10/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|