FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNILINK SYSTEM 602
K Number: K892351
·
Decision May 26, 1989
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
7
Applicant Total
14
Review Days
51
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Basic Information
- Device Name
- MAGNILINK SYSTEM 602
- K Number
- K892351
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5820
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Coburn Optical Ind., Inc.
- Date Received
- April 5, 1989
- Decision Date
- May 26, 1989
- Product Code
- HJG
- 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 |
|---|---|---|---|
| HJG | System, Reading, Television, Closed-Circuit | FDA class 1 | Ophthalmic |
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Other Clearances by Coburn Optical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892350 | MAGNILINK SYSTEM 402/5 | May 26, 1989 | Substantially Equivalent |
| K892349 | MAGNILINK SYSTEM 209 | May 26, 1989 | Substantially Equivalent |
| K892347 | MAGNILINK SYSTEM 101 | May 26, 1989 | Substantially Equivalent |
| K892348 | MAGNILINK SYSTEM 201 | May 26, 1989 | Substantially Equivalent |
| K862188 | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE | Aug 21, 1986 | Substantially Equivalent |
| K853457 | COBURN I/A SYSTEM | Oct 15, 1985 | Substantially Equivalent |
| K821737 | DISP. MICROSURGICAL KNIVES | Jul 2, 1982 | Substantially Equivalent |
| K812441 | DI-CROWN | Oct 6, 1981 | Substantially Equivalent |
| K803159 | AUTOMATED PERIMETERS | Feb 4, 1981 | Substantially Equivalent |
| K801659 | BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE | Sep 9, 1980 | Substantially Equivalent |