510(k) K853556
K853556 is an FDA 510(k) premarket notification submitted by Randwal Instrument Co., Inc. for the device "LASER IRAS". The FDA issued a decision of Substantially Equivalent on November 1, 1985. The device falls under product code HPJ (Instrument, Visual Field, Laser), a Class II device regulated under 21 CFR 886.1360. Randwal Instrument Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1985
- Date Received
- August 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Visual Field, Laser
- Device Class
- Class II
- Regulation Number
- 886.1360
- Review Panel
- OP
- Submission Type