510(k) K945395
K945395 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER MIRROR WARMER". The FDA issued a decision of Substantially Equivalent on January 18, 1995. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1995
- Date Received
- November 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Examining/Treatment, Ent
- Device Class
- Class I
- Regulation Number
- 874.5300
- Review Panel
- EN
- Submission Type