The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Truzone Pfm Disposable Mouthpiece.
| Device ID | K944512 |
| 510k Number | K944512 |
| Device Name: | TRUZONE PFM DISPOSABLE MOUTHPIECE |
| Classification | Mouthpiece, Breathing |
| Applicant | MONAGHAN MEDICAL CORP. FRANKLYN BLDG., RT. 9 NORTH P.O. BOX 2805 Plattsburgh, NY 12901 |
| Contact | James A Cochie |
| Correspondent | James A Cochie MONAGHAN MEDICAL CORP. FRANKLYN BLDG., RT. 9 NORTH P.O. BOX 2805 Plattsburgh, NY 12901 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1994-11-02 |