510(k) K830336
K830336 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "DORC INTRAOCULAR ELECTROMAGNET". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code HPO (Magnet, Ac-Powered), a Class II device regulated under 21 CFR 886.4440. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1983
- Date Received
- February 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnet, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4440
- Review Panel
- OP
- Submission Type