FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DI-CROWN
K Number: K812441
·
Decision Oct 6, 1981
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
14
Review Days
41
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Basic Information
- Device Name
- DI-CROWN
- K Number
- K812441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Coburn Optical Ind., Inc.
- Date Received
- August 26, 1981
- Decision Date
- October 6, 1981
- Product Code
- HQG
- 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | FDA class 1 | Ophthalmic |
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Other Clearances by Coburn Optical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892351 | MAGNILINK SYSTEM 602 | May 26, 1989 | Substantially Equivalent |
| 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 |
| K803159 | AUTOMATED PERIMETERS | Feb 4, 1981 | Substantially Equivalent |
| K801659 | BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE | Sep 9, 1980 | Substantially Equivalent |