The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Burr Hole Cover, Model Xx.
| Device ID | K001096 |
| 510k Number | K001096 |
| Device Name: | BURR HOLE COVER, MODEL XX |
| Classification | Cover, Burr Hole |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994747808 | K001096 | 000 |
| 00763000210205 | K001096 | 000 |
| 00763000210212 | K001096 | 000 |
| 00763000210229 | K001096 | 000 |
| 00763000004972 | K001096 | 000 |
| 00763000004989 | K001096 | 000 |
| 00763000004996 | K001096 | 000 |
| 00763000004965 | K001096 | 000 |
| 20613994292791 | K001096 | 000 |
| 20613994747895 | K001096 | 000 |
| 00613994747204 | K001096 | 000 |
| 00763000210199 | K001096 | 000 |