The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for H.p. Medical Grade Silicone Tubing.
| Device ID | K780470 |
| 510k Number | K780470 |
| Device Name: | H.P. MEDICAL GRADE SILICONE TUBING |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-22 |
| Decision Date | 1978-04-27 |