The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Disposable Syringes.
Device ID | K030683 |
510k Number | K030683 |
Device Name: | NIPRO DISPOSABLE SYRINGES |
Classification | Syringe, Piston |
Applicant | NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
Contact | Kaelyn B Hadley |
Correspondent | Kaelyn B 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 | 2003-03-05 |
Decision Date | 2003-10-31 |
Summary: | summary |