510(k) K781650
K781650 is an FDA 510(k) premarket notification submitted by Clifford M. Terry, M.C. for the device "TERRY KERATOMETER". The FDA issued a decision of Substantially Equivalent on Oct 17, 1978. The device falls under product code HJA (Photokeratoscope), a Class I device regulated under 21 CFR 886.1350.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 1978
- Date Received
- Sep 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Photokeratoscope
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt