510(k) K851555
K851555 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "OPTHALMIC BAR PRISM". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code HKW (Prism, Bar, Ophthalmic), a Class I device regulated under 21 CFR 886.1650. Roseburg SA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1985
- Date Received
- April 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prism, Bar, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1650
- Review Panel
- OP
- Submission Type