510(k) K931546
K931546 is an FDA 510(k) premarket notification submitted by Infinitech, Inc. for the device "END-IRRIGATING ENDOILLUMINATOR". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Infinitech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1994
- Date Received
- March 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type