Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K862909 |
Device Name |
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM |
Applicant |
INTL. MEDICAL DEVICES LTD. |
19355 BUSINESS CENTER DR. |
SUITE 8 |
NORTHRIDGE,
CA
91324
|
|
Applicant Contact |
MARCIA WEISS |
Correspondent |
INTL. MEDICAL DEVICES LTD. |
19355 BUSINESS CENTER DR. |
SUITE 8 |
NORTHRIDGE,
CA
91324
|
|
Correspondent Contact |
MARCIA WEISS |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 07/31/1986 |
Decision Date | 09/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|