DURALASTIC SHEETING II
Device Facts
| Record ID | K961057 |
|---|---|
| Device Name | DURALASTIC SHEETING II |
| Applicant | Rand Scientific Corp. |
| Product Code | MIB · Ear, Nose, Throat |
| Decision Date | May 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
