Device Classification Name |
Solution-Test Standard-Conductivity, Dialysis
|
510(k) Number |
K851362 |
Device Name |
STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF |
Applicant |
RNA MEDICAL CORP. |
21 CUMMINGS PARK |
SUITE 228 |
WOBURN,
MA
01801
|
|
Applicant Contact |
ADOLPH E D'AMICO |
Correspondent |
RNA MEDICAL CORP. |
21 CUMMINGS PARK |
SUITE 228 |
WOBURN,
MA
01801
|
|
Correspondent Contact |
ADOLPH E D'AMICO |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/04/1985 |
Decision Date | 06/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|