The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Light Saber Spinal Needle.
Device ID | K021084 |
510k Number | K021084 |
Device Name: | LIGHT SABER SPINAL NEEDLE |
Classification | Syringe, Piston |
Applicant | MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Contact | Kim S Devito |
Correspondent | Kim S Devito MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-04 |
Decision Date | 2002-07-03 |
Summary: | summary |