510(k) K964312
K964312 is an FDA 510(k) premarket notification submitted by Mentor Ophthalmics, Inc. for the device "MENTOR TONO-PEN 3". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Mentor Ophthalmics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1996
- Date Received
- October 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type