The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Disposable Syringe With Or Without Needle.
Device ID | K051574 |
510k Number | K051574 |
Device Name: | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
Classification | Syringe, Piston |
Applicant | NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
Contact | Kaelyn Hadley |
Correspondent | Kaelyn Hadley NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-14 |
Decision Date | 2005-08-26 |
Summary: | summary |