Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K897102 |
Device Name |
HYDRASORB(TM) |
Applicant |
AVITAR, INC. |
250 TURNPIKE ST. |
CANTON,
MA
02021
|
|
Applicant Contact |
PAUL H PATRONE |
Correspondent |
AVITAR, INC. |
250 TURNPIKE ST. |
CANTON,
MA
02021
|
|
Correspondent Contact |
PAUL H PATRONE |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 12/21/1989 |
Decision Date | 04/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|