The following data is part of a premarket notification filed by Amici, Inc. with the FDA for Amici Tru-fit Soft Plastic Mouthpiece.
| Device ID | K903694 |
| 510k Number | K903694 |
| Device Name: | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | AMICI, INC. 518 VINCENT ST. Spring City, PA 19475 |
| Contact | Michael Bono |
| Correspondent | Michael Bono AMICI, INC. 518 VINCENT ST. Spring City, PA 19475 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-15 |
| Decision Date | 1990-10-03 |