The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Prolong, Models Pl 18040tc, Pl18050tgc, Pl18100tgc, Pl18150tgc,.
| Device ID | K102007 |
| 510k Number | K102007 |
| Device Name: | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, |
| Classification | Anesthesia Conduction Kit |
| Applicant | LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651452246 | K102007 | 000 |
| 10193494327726 | K102007 | 000 |
| 10193494327740 | K102007 | 000 |
| 10193494327757 | K102007 | 000 |
| 10193494327764 | K102007 | 000 |
| 10193494386044 | K102007 | 000 |
| 10680651136623 | K102007 | 000 |
| 30680651327711 | K102007 | 000 |
| 10680651327724 | K102007 | 000 |
| 30680651327742 | K102007 | 000 |
| 30680651327759 | K102007 | 000 |
| 10680651327762 | K102007 | 000 |
| 30680651386046 | K102007 | 000 |
| 10193494327719 | K102007 | 000 |