510(k) K830008
K830008 is an FDA 510(k) premarket notification submitted by Surgidev Corp. for the device "KARICKHOFF KERATOSCOPE". The FDA issued a decision of Substantially Equivalent on Jan 26, 1983. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350. Surgidev Corp. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 1983
- Date Received
- Jan 3, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Keratoscope, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt