510(k) K760707
K760707 is an FDA 510(k) premarket notification submitted by Ritter Co. for the device "RITTER STARLIGHT DENTAL OPERATING LIGHT". The FDA issued a decision of Substantially Equivalent on October 5, 1976. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Ritter Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1976
- Date Received
- September 23, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Operating, Dental
- Device Class
- Class I
- Regulation Number
- 872.4630
- Review Panel
- DE
- Submission Type