Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K203792 |
Device Name |
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle |
Applicant |
Pikdare S.p.A |
Via Saldarini Catelli 10 |
Casnate con Bernate,
IT
22070
|
|
Applicant Contact |
Roberta Zanoni |
Correspondent |
Pikdare S.p.A |
Via Saldarini Catelli 10 |
Casnate con Bernate,
IT
22070
|
|
Correspondent Contact |
Roberta Zanoni |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 12/28/2020 |
Decision Date | 01/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|