The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model Skck Sterile Knob Cover Kit.
| Device ID | K870662 |
| 510k Number | K870662 |
| Device Name: | MODEL SKCK STERILE KNOB COVER KIT |
| Classification | Stimulator, Nerve, Ac-powered |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Andrew C Kyle |
| Correspondent | Andrew C Kyle LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | BXM |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-19 |
| Decision Date | 1987-10-28 |