510(k) K951627
K951627 is an FDA 510(k) premarket notification submitted by Infinitech, Inc. for the device "INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 1995. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Infinitech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1995
- Date Received
- April 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type