| Device Classification Name |
System, Communication, Powered
|
| 510(k) Number |
K903605 |
| Device Name |
CINTEX |
| Applicant |
| Nanopac, Inc. |
| 4833 S. Sheridan Rd. |
| Suite 402 |
|
Tulsa,
OK
74145
|
|
| Applicant Contact |
CHARLES A LOOP |
| Correspondent |
| Nanopac, Inc. |
| 4833 S. Sheridan Rd. |
| Suite 402 |
|
Tulsa,
OK
74145
|
|
| Correspondent Contact |
CHARLES A LOOP |
| Regulation Number | 890.3710 |
| Classification Product Code |
|
| Date Received | 08/08/1990 |
| Decision Date | 09/14/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|