The following data is part of a premarket notification filed by Pain Concepts, Inc. with the FDA for Dekompressor Percutaneous Lumbar Discectomy Probe.
| Device ID | K013513 |
| 510k Number | K013513 |
| Device Name: | DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE |
| Classification | Arthroscope |
| Applicant | PAIN CONCEPTS, INC. 8001 IRVINE CENTER DR. 4TH FLOOR Irvine, CA 92618 |
| Contact | Russell Pflueger |
| Correspondent | Russell Pflueger PAIN CONCEPTS, INC. 8001 IRVINE CENTER DR. 4TH FLOOR Irvine, CA 92618 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-01-17 |