| Device Classification Name |
Trap, Sterile Specimen
|
| 510(k) Number |
K791847 |
| Device Name |
ASPRI-LUKE |
| Applicant |
| Medical Marketing Group |
| 5335 Dividend Dr. |
|
Decatur,
GA
30035
|
|
| Applicant Contact |
TIMOTHY GOLDEN |
| Correspondent |
| Medical Marketing Group |
| 5335 Dividend Dr. |
|
Decatur,
GA
30035
|
|
| Correspondent Contact |
TIMOTHY GOLDEN |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 09/19/1979 |
| Decision Date | 10/02/1979 |
| 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
|
|
|