The following data is part of a premarket notification filed by Medspec Corp. with the FDA for Sterile Silicone Tubing.
| Device ID | K810071 |
| 510k Number | K810071 |
| Device Name: | STERILE SILICONE TUBING |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | MEDSPEC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-12 |