The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for 2.1mm Semi-rigid Neuroview Scissors/2.0omm Semi-rigid Neuroview Grasping Forceps.
Device ID | K965078 |
510k Number | K965078 |
Device Name: | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS |
Classification | Endoscope, Neurological |
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 | GWG |
CFR Regulation Number | 882.1480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-19 |
Decision Date | 1997-03-06 |