The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Lumbar Drainage Accessory Kit.
| Device ID | K970658 |
| 510k Number | K970658 |
| Device Name: | LUMBAR DRAINAGE ACCESSORY KIT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Contact | Terry N Layton, Ph.d. |
| Correspondent | Terry N Layton, Ph.d. INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-21 |
| Decision Date | 1997-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072553 | K970658 | 000 |
| 10381780072416 | K970658 | 000 |