The following data is part of a premarket notification filed by Westmark Enterprises, Inc. with the FDA for Plastic Mouth Barrier Hsv-i.
| Device ID | K853266 |
| 510k Number | K853266 |
| Device Name: | PLASTIC MOUTH BARRIER HSV-I |
| Classification | Mouthpiece, Breathing |
| 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 | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-29 |