510(k) K860648
K860648 is an FDA 510(k) premarket notification submitted by Precision Instruments, Inc. for the device "BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA". The FDA issued a decision of SN on March 25, 1986. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Precision Instruments, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 25, 1986
- Date Received
- February 20, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trephine, Manual, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type