510(k) K860330
K860330 is an FDA 510(k) premarket notification submitted by Med-Tech Develoment Corp. for the device "MAKLAKOV STYLE TONOMETER". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Med-Tech Develoment Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1986
- Date Received
- January 29, 1986
- 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