510(k) K800238
K800238 is an FDA 510(k) premarket notification submitted by Hagg-Streit Service, Inc. for the device "MOIRE FRINGE VISOMETER AFTER LOTMAR". The FDA issued a decision of Substantially Equivalent on March 10, 1980. The device falls under product code HKL (Retinoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1780. Hagg-Streit Service, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1980
- Date Received
- February 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type