The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Prolong, Models Pl50, Pl100, Pl150.
| Device ID | K001129 |
| 510k Number | K001129 |
| Device Name: | PROLONG, MODELS PL50, PL100, PL150 |
| Classification | Anesthesia Conduction Kit |
| Applicant | LIFE-TECH INTL., INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH INTL., 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 | 2000-04-07 |
| Decision Date | 2000-07-06 |