Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K925020 |
Device Name |
TRACHEOSTOMY CARE KIT (STERILE) |
Applicant |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Applicant Contact |
FELIX B SANTOS |
Correspondent |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Correspondent Contact |
FELIX B SANTOS |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 09/24/1992 |
Decision Date | 07/07/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|