510(k) K932761
K932761 is an FDA 510(k) premarket notification submitted by Professional Positioners, Inc. for the device "SOFT-WEAR HEADGEAR AND SAFETY MODULES". The FDA issued a decision of Substantially Equivalent on October 7, 1993. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Professional Positioners, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1993
- Date Received
- June 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headgear, Extraoral, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5500
- Review Panel
- DE
- Submission Type