510(k) K830290
K830290 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "DORC CONTACT/PHOTO DERATOSCOPE". The FDA issued a decision of Substantially Equivalent on Mar 9, 1983. The device falls under product code HJA (Photokeratoscope), a Class I device regulated under 21 CFR 886.1350. Jedmed Instrument Co. has 92 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 9, 1983
- Date Received
- Jan 27, 1983
- 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