510(k) K871646
K871646 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "TANNE CORNEAL CUTTING BLOCK". The FDA issued a decision of Substantially Equivalent on May 18, 1987. The device falls under product code HNJ (Punch, Corneo-Scleral), a Class I device regulated under 21 CFR 886.4350. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1987
- Date Received
- April 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Corneo-Scleral
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type