510(k) K770685
K770685 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "LIGHT, EXAMINING, DENTAL, ULTRA VIOLET". The FDA issued a decision of Substantially Equivalent on April 26, 1977. The device falls under product code EAQ (Detector, Ultraviolet), a Class II device regulated under 21 CFR 872.6350. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1977
- Date Received
- April 12, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Ultraviolet
- Device Class
- Class II
- Regulation Number
- 872.6350
- Review Panel
- DE
- Submission Type