The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Piston Syringe.
Device ID | K951871 |
510k Number | K951871 |
Device Name: | PISTON SYRINGE |
Classification | Syringe, Piston |
Applicant | BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
Contact | William E Mckay |
Correspondent | William E Mckay BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-21 |
Decision Date | 1995-06-21 |