The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Mr Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002.
Device ID | K062230 |
510k Number | K062230 |
Device Name: | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 |
Classification | Laryngoscope, Rigid |
Applicant | MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Contact | John Mcneirney |
Correspondent | John Mcneirney MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-02 |
Decision Date | 2006-08-31 |
Summary: | summary |