Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K885139 |
Device Name |
MODIFIED ADULT CRICOTHYROIDOTOMY KIT |
Applicant |
PERTRACH |
BOX 1158 |
109 KELLY DR. |
BRIDGEPORT,
WV
26330
|
|
Applicant Contact |
TOYE, MD |
Correspondent |
PERTRACH |
BOX 1158 |
109 KELLY DR. |
BRIDGEPORT,
WV
26330
|
|
Correspondent Contact |
TOYE, MD |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 12/15/1988 |
Decision Date | 05/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|