The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Stimpro, Models Sp22050, Sp20100, Spp19050, Spp19100, Spp19150, Spc19050, Spc19100, Spc19150, Spc18050,spc18100,spc18150.
| Device ID | K082772 |
| 510k Number | K082772 |
| Device Name: | STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2009-02-09 |