Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K936094 |
Device Name |
PREPARE LOCK |
Applicant |
PREPARE, INC. |
P.O. BOX 30440 |
SANTA BARBARA,
CA
93130
|
|
Applicant Contact |
ANGEL L ISCOVICH, M.D. |
Correspondent |
PREPARE, INC. |
P.O. BOX 30440 |
SANTA BARBARA,
CA
93130
|
|
Correspondent Contact |
ANGEL L ISCOVICH, M.D. |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 12/22/1993 |
Decision Date | 02/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|