| Device Classification Name |
Catheter And Tip, Suction
|
| 510(k) Number |
K860927 |
| Device Name |
HD CRYSTALINE SUCTION TIP |
| Applicant |
| Hospital Disposables, Inc. |
| 104 Wheeler St. |
|
Portland,
TN
37148
|
|
| Applicant Contact |
CUDE, III |
| Correspondent |
| Hospital Disposables, Inc. |
| 104 Wheeler St. |
|
Portland,
TN
37148
|
|
| Correspondent Contact |
CUDE, III |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 03/11/1986 |
| Decision Date | 03/27/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|