510(k) K955503
K955503 is an FDA 510(k) premarket notification submitted by Jonathan A. Parker, D.D.S. for the device "ADJUSTABLE PM POSITIONER". The FDA issued a decision of Substantially Equivalent on February 8, 1996. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Jonathan A. Parker, D.D.S. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1996
- Date Received
- December 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Repositioning
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type