| Device Classification Name |
Bedding, Disposable, Medical
|
| 510(k) Number |
K905003 |
| Device Name |
BIO-GUARD SHAVE PREP TRAY |
| Applicant |
| Network Medical Systems, Inc. |
| 4901 Milwee, #202 |
|
Houston,
TX
77092
|
|
| Applicant Contact |
SAM HAMOUIE |
| Correspondent |
| Network Medical Systems, Inc. |
| 4901 Milwee, #202 |
|
Houston,
TX
77092
|
|
| Correspondent Contact |
SAM HAMOUIE |
| Regulation Number | 880.6060 |
| Classification Product Code |
|
| Date Received | 11/07/1990 |
| Decision Date | 12/28/1990 |
| Decision |
Substantially Equivalent - Kit
(SESK) |
| 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
|
|
|