Device Classification Name |
catheter, peritoneal
|
510(k) Number |
K854812 |
Device Name |
NELSON-JUNG PLEURAL CATH |
Applicant |
RESEARCH MEDICAL, INC. |
1847 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
MICHAEL N KELLY |
Correspondent |
RESEARCH MEDICAL, INC. |
1847 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
MICHAEL N KELLY |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 12/03/1985 |
Decision Date | 02/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|