The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Minrad Drts Light Saber Syringe.
Device ID | K981140 |
510k Number | K981140 |
Device Name: | MINRAD DRTS LIGHT SABER SYRINGE |
Classification | Syringe, Piston |
Applicant | MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
Contact | Thomas L Parker |
Correspondent | Thomas L Parker MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-30 |
Decision Date | 1998-06-25 |