Device Classification Name |
Pack, Hot Or Cold, Disposable
|
510(k) Number |
K953542 |
Device Name |
COLDGEL |
Applicant |
PRISM TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSETIN |
Correspondent |
PRISM TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSETIN |
Regulation Number | 890.5710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/28/1995 |
Decision Date | 10/30/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|