Device Classification Name |
System, Communication, Powered
|
510(k) Number |
K903605 |
Device Name |
CINTEX |
Applicant |
NANOPAC, INC. |
4833 SOUTH SHERIDAN RD. |
SUITE 402 |
TULSA,
OK
74145
|
|
Applicant Contact |
CHARLES A LOOP |
Correspondent |
NANOPAC, INC. |
4833 SOUTH 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
|
|
|