Device Classification Name |
Needle, Fistula
|
510(k) Number |
K002813 |
Device Name |
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE |
Applicant |
NIPRO MEDICAL CORP. |
510 STONEMONT DR. |
WESTON,
FL
33326
|
|
Applicant Contact |
RICHARD D BLISS |
Correspondent |
NIPRO MEDICAL CORP. |
510 STONEMONT DR. |
WESTON,
FL
33326
|
|
Correspondent Contact |
RICHARD D BLISS |
Regulation Number | 876.5540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/08/2000 |
Decision Date | 11/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|