Device Classification Name |
subsystem, water purification
|
510(k) Number |
K802474 |
Device Name |
CMR 300, ROWATER TREATMENT UNIT |
Applicant |
U-MARC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
U-MARC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 10/09/1980 |
Decision Date | 12/15/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|