Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K901920 |
Device Name |
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE |
Applicant |
PRIMECARE, INC. |
23991 IRONHEAD LN. |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
JOSEPH H BALES |
Correspondent |
PRIMECARE, INC. |
23991 IRONHEAD LN. |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
JOSEPH H BALES |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 04/30/1990 |
Decision Date | 08/17/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|