| Device Classification Name |
Electrode, Cutaneous
|
| 510(k) Number |
K896936 |
| Device Name |
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP |
| Applicant |
| Labeltape Meditect, Inc. |
| 4275 Airwest Dr., SE |
| P.O. Box 8823 |
|
Grand Rapids,
MI
49508
|
|
| Applicant Contact |
LORA L JONES |
| Correspondent |
| Labeltape Meditect, Inc. |
| 4275 Airwest Dr., SE |
| P.O. Box 8823 |
|
Grand Rapids,
MI
49508
|
|
| Correspondent Contact |
LORA L JONES |
| Regulation Number | 882.1320 |
| Classification Product Code |
|
| Date Received | 12/13/1989 |
| Decision Date | 01/22/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|