FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RARE EARTH INTRA-OCULAR MAGNET
K Number: K860960
·
Decision Mar 31, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
4
Applicant Total
17
Review Days
18
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Basic Information
- Device Name
- RARE EARTH INTRA-OCULAR MAGNET
- K Number
- K860960
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4445
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ameritek, Inc.
- Date Received
- March 13, 1986
- Decision Date
- March 31, 1986
- Product Code
- HPN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HPN | Magnet, Permanent | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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