FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EYE BARRIER
K Number: K863182
·
Decision Sep 3, 1986
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
34
Review Days
15
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Basic Information
- Device Name
- EYE BARRIER
- K Number
- K863182
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- O.R. Concepts, Inc.
- Date Received
- August 19, 1986
- Decision Date
- September 3, 1986
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQZ), ordered by most recent decision date.
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
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SPECTACLE FRAME
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FDA Class 1
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SPECTACLE FRAME OR EYEGLASS FRAMES
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FDA Class 1
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SPECTACLE FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
OPTICAL FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by O.R. Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | Aug 17, 1994 | Substantially Equivalent |
| K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE | May 16, 1994 | Substantially Equivalent |
| K935971 | FLOWGUN ELECTROCAUTERY PROBES | May 16, 1994 | Substantially Equivalent |
| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | Mar 7, 1994 | Substantially Equivalent |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | Oct 15, 1993 | Substantially Equivalent |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | Sep 24, 1993 | Substantially Equivalent |
| K922197 | INSUFFLATOR TUBING KIT | Sep 24, 1993 | Substantially Equivalent |
| K932449 | DR. FOG | Aug 11, 1993 | Substantially Equivalent |
| K925147 | ORC 10.0MM SUCTION PROBE | Jun 25, 1993 | Substantially Equivalent |
| K925024 | ORC TAPPERED IRRIGATING PROBE | May 21, 1993 | Substantially Equivalent |