SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
Device Facts
| Record ID | K000048 |
|---|---|
| Device Name | SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 |
| Applicant | Biosurgical Corp. |
| Product Code | FMF · General Hospital |
| Decision Date | Jan 31, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
