The following data is part of a premarket notification filed by Westmark Enterprises, Inc. with the FDA for Plastic Mouth Barrier Hcv-e.
| Device ID | K860780 |
| 510k Number | K860780 |
| Device Name: | PLASTIC MOUTH BARRIER HCV-E |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | WESTMARK ENTERPRISES, INC. 8710 TRUMBULL AVE. Skokie, IL 60076 |
| Contact | Mark D Westfall |
| Correspondent | Mark D Westfall WESTMARK ENTERPRISES, INC. 8710 TRUMBULL AVE. Skokie, IL 60076 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-04-02 |