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 |