The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Safe Vent System.
| Device ID | K942394 |
| 510k Number | K942394 |
| Device Name: | SAFE VENT SYSTEM |
| Classification | Syringe, Piston |
| Applicant | INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
| Contact | Roger V Molina |
| Correspondent | Roger V Molina INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1995-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884527004228 | K942394 | 000 |