Device Classification Name |
system, urine drainage, closed, for nonindwelling catheter, sterile
|
510(k) Number |
K961906 |
Device Name |
UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 |
Applicant |
SPECTRUM MEDSYSTEMS CORP. |
2166 MICHELSON DR. |
IRVINE,
CA
92715 -1304
|
|
Applicant Contact |
THOMAS L HURSMAN |
Correspondent |
SPECTRUM MEDSYSTEMS CORP. |
2166 MICHELSON DR. |
IRVINE,
CA
92715 -1304
|
|
Correspondent Contact |
THOMAS L HURSMAN |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 05/16/1996 |
Decision Date | 11/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|