510(k) K854054
K854054 is an FDA 510(k) premarket notification submitted by Cutler Medical Instruments for the device "PLACIDO DISC". The FDA issued a decision of Substantially Equivalent on Dec 27, 1985. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350. Cutler Medical Instruments has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 27, 1985
- Date Received
- Oct 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Keratoscope, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt