The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Light Sabre Spinal Access Device.
Device ID | K071814 |
510k Number | K071814 |
Device Name: | LIGHT SABRE SPINAL ACCESS DEVICE |
Classification | Instrument, Biopsy |
Applicant | MINRAD, INC. 50 COBHAM DR. Orchard Park, NY 14127 -4121 |
Contact | John Mcneirney |
Correspondent | John Mcneirney MINRAD, INC. 50 COBHAM DR. Orchard Park, NY 14127 -4121 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-02 |
Decision Date | 2007-10-16 |
Summary: | summary |