Device Classification Name |
pack, hot or cold, water circulating
|
510(k) Number |
K761254 |
Device Name |
BAND-AGE ICE-BANDAGE |
Applicant |
SURGICOT, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SURGICOT, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 890.5720
|
Classification Product Code |
|
Date Received | 12/13/1976 |
Decision Date | 02/24/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|