The following data is part of a premarket notification filed by Hygoplastic, Inc. with the FDA for High Vac.
| Device ID | K920492 |
| 510k Number | K920492 |
| Device Name: | HIGH VAC |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | HYGOPLASTIC, INC. 1494 LAKESHORE RD. Grafton, WI 53024 |
| Contact | Gunnar Wallin |
| Correspondent | Gunnar Wallin HYGOPLASTIC, INC. 1494 LAKESHORE RD. Grafton, WI 53024 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-03 |
| Decision Date | 1992-05-11 |