510(k) K812605
K812605 is an FDA 510(k) premarket notification submitted by Venture Technology, Inc. for the device "FIBER OPTIC LIGHT SOURCE I". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Venture Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1981
- Date Received
- September 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Fiber Optic, Dental
- Device Class
- Class I
- Regulation Number
- 872.4620
- Review Panel
- DE
- Submission Type