510(k) K852424
K852424 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX COMPARATIVE SURGICAL KERATOMETER". The FDA issued a decision of Substantially Equivalent on September 11, 1985. The device falls under product code HJB (Instrument, Measuring, Corneal Radius), a Class I device regulated under 21 CFR 886.1450. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1985
- Date Received
- June 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Measuring, Corneal Radius
- Device Class
- Class I
- Regulation Number
- 886.1450
- Review Panel
- OP
- Submission Type