The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Neuroview Instrument Holder, Model 300-33.
| Device ID | K992006 |
| 510k Number | K992006 |
| Device Name: | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 |
| Classification | Endoscope Holder |
| Applicant | INTEGRA NEUROCARE LLC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy A Mathewson |
| Correspondent | Nancy A Mathewson INTEGRA NEUROCARE LLC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | OCV |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 1999-08-17 |
| Summary: | summary |