510(k) K831702
K831702 is an FDA 510(k) premarket notification submitted by Miami Eye Technology, Inc. for the device "RARE-EARTH INTRA-OCULAR MAGNET". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code HPN (Magnet, Permanent), a Class I device regulated under 21 CFR 886.4445. Miami Eye Technology, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1983
- Date Received
- May 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnet, Permanent
- Device Class
- Class I
- Regulation Number
- 886.4445
- Review Panel
- OP
- Submission Type