510(k) K813313
K813313 is an FDA 510(k) premarket notification submitted by Design Research Assoc., Inc. for the device "BIOMICROSCOPY CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Design Research Assoc., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1982
- Date Received
- November 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type