The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Contistim Continuous Stimulating Catheter Nerve Block Set.
| Device ID | K052954 |
| 510k Number | K052954 |
| Device Name: | CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET |
| Classification | Anesthesia Conduction Kit |
| Applicant | LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2006-02-15 |
| Summary: | summary |