The following data is part of a premarket notification filed by Jonathan A. Parker, D.d.s. with the FDA for Adjustable Pm Positioner.
Device ID | K955503 |
510k Number | K955503 |
Device Name: | ADJUSTABLE PM POSITIONER |
Classification | Device, Jaw Repositioning |
Applicant | JONATHAN A. PARKER, D.D.S. 1801 K STREET, N.W. Washington, DC 20006 |
Contact | Robert J Stefani |
Correspondent | Robert J Stefani JONATHAN A. PARKER, D.D.S. 1801 K STREET, N.W. Washington, DC 20006 |
Product Code | LQZ |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-01 |
Decision Date | 1996-02-08 |