| Device Classification Name |
Pack, Hot Or Cold, Water Circulating
|
| 510(k) Number |
K883681 |
| Device Name |
DAS SPORT PUMP(TM) |
| Applicant |
| D.A. Schulman, Inc. |
| 7701 Newton Ave. N. |
|
Brooklyn Park,
MN
55444
|
|
| Applicant Contact |
A SCHULMAN |
| Correspondent |
| D.A. Schulman, Inc. |
| 7701 Newton Ave. N. |
|
Brooklyn Park,
MN
55444
|
|
| Correspondent Contact |
A SCHULMAN |
| Regulation Number | 890.5720 |
| Classification Product Code |
|
| Date Received | 08/29/1988 |
| Decision Date | 09/30/1988 |
| 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
|
|
|