| 510(k) Number |
K870044 |
| Device Name |
MCD SPECIALTY BRAND NEEDLE COUNTERS |
| Applicant |
| Medical Concepts Development, Inc. |
| 330 Chester St. |
|
St. Paul,
MN
55107
|
|
| Applicant Contact |
LEE ANNETT |
| Correspondent |
| Medical Concepts Development, Inc. |
| 330 Chester St. |
|
St. Paul,
MN
55107
|
|
| Correspondent Contact |
LEE ANNETT |
| Date Received | 01/05/1987 |
| Decision Date | 01/21/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|