Device Classification Name |
needle, fistula
|
510(k) Number |
K100520 |
Device Name |
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER |
Applicant |
NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. |
MIAMI,
FL
33172
|
|
Applicant Contact |
JESSICA OSWALD |
Correspondent |
NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. |
MIAMI,
FL
33172
|
|
Correspondent Contact |
JESSICA OSWALD |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 02/23/2010 |
Decision Date | 03/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|