Device Classification Name |
Pack, Hot Or Cold, Disposable
|
510(k) Number |
K902839 |
Device Name |
LIBERTY HOT PACK AND LIBERTY KOLD PACK |
Applicant |
LIBERTY ENT. |
P.O. BOX 639 |
ROUTE 5S |
AMSTERDAM,
NY
12010
|
|
Applicant Contact |
BILL ZIESE |
Correspondent |
LIBERTY ENT. |
P.O. BOX 639 |
ROUTE 5S |
AMSTERDAM,
NY
12010
|
|
Correspondent Contact |
BILL ZIESE |
Regulation Number | 890.5710 |
Classification Product Code |
|
Date Received | 06/28/1990 |
Decision Date | 07/25/1990 |
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
|
|
|