510(k) K860960
K860960 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "RARE EARTH INTRA-OCULAR MAGNET". The FDA issued a decision of Substantially Equivalent on March 31, 1986. The device falls under product code HPN (Magnet, Permanent), a Class I device regulated under 21 CFR 886.4445. Ameritek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1986
- Date Received
- March 13, 1986
- 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