510(k) K864639
K864639 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "REUSABLE SURGICAL KERATOSCOPE". The FDA issued a decision of Substantially Equivalent on December 29, 1986. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1986
- Date Received
- November 26, 1986
- 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