Device Classification Name |
Catheters, Suction, Tracheobronchial
|
510(k) Number |
K921851 |
Device Name |
4 SURE TM SUCTION CATHETERS & KITS |
Applicant |
BOSTON PACIFIC MEDICAL, INC. |
636 BEACON ST. |
UNIT 204 |
BOSTON,
MA
02215
|
|
Applicant Contact |
RANDALL GREEN |
Correspondent |
BOSTON PACIFIC MEDICAL, INC. |
636 BEACON ST. |
UNIT 204 |
BOSTON,
MA
02215
|
|
Correspondent Contact |
RANDALL GREEN |
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 04/17/1992 |
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
|
|
|