The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Medical Grade Silicone Elastomer Tubing.
| Device ID | K781087 |
| 510k Number | K781087 |
| Device Name: | MEDICAL GRADE SILICONE ELASTOMER TUBING |
| Classification | Tubing, Fluid Delivery |
| Applicant | MCGHAN MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-29 |
| Decision Date | 1978-11-22 |