The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Probloc Insulated Needles.
| Device ID | K926349 |
| 510k Number | K926349 |
| Device Name: | PROBLOC INSULATED NEEDLES |
| Classification | Electrode, Needle |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred C Coats |
| Correspondent | Alfred C Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-07-29 |