The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Prolong-ex, Models: Plex-50cs, Plex-100cs, Plex-150cs.
| Device ID | K072050 |
| 510k Number | K072050 |
| Device Name: | PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS |
| Classification | Catheter, Conduction, Anesthetic |
| 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 | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-26 |
| Decision Date | 2007-10-18 |