The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for 1.2mm Disposable Neuroview Preformed Endoscope.
Device ID | K950705 |
510k Number | K950705 |
Device Name: | 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE |
Classification | Arthroscope |
Applicant | NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
Contact | Karen U Salinas |
Correspondent | Karen U Salinas NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-15 |
Decision Date | 1995-05-09 |