510(k) K960767
K960767 is an FDA 510(k) premarket notification submitted by Scieran Technologies, Inc. for the device "LIGHT COMMANDER". The FDA issued a decision of Substantially Equivalent on August 26, 1996. The device falls under product code FCT (Headlight, Fiberoptic Focusing), a Class II device regulated under 21 CFR 886.4335. Scieran Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1996
- Date Received
- February 26, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headlight, Fiberoptic Focusing
- Device Class
- Class II
- Regulation Number
- 886.4335
- Review Panel
- OP
- Submission Type