510(k) K851557
K851557 is an FDA 510(k) premarket notification submitted by Luneau SA for the device "ANESTHESIOMETER". The FDA issued a decision of Substantially Equivalent on May 30, 1985. The device falls under product code HJC (Esthesiometer, Ocular), a Class I device regulated under 21 CFR 886.1040. Luneau SA has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1985
- Date Received
- April 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esthesiometer, Ocular
- Device Class
- Class I
- Regulation Number
- 886.1040
- Review Panel
- OP
- Submission Type