510(k) K861749
K861749 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code FSP (Loupe, Diagnostic/Surgical), a Class I device regulated under 21 CFR 878.4800. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1986
- Date Received
- May 6, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Loupe, Diagnostic/Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type