FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTHALMIC BAR PRISM
K Number: K851555
·
Decision May 23, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
1
Applicant Total
24
Review Days
37
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Basic Information
- Device Name
- OPTHALMIC BAR PRISM
- K Number
- K851555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1650
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- April 16, 1985
- Decision Date
- May 23, 1985
- Product Code
- HKW
- 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 |
|---|---|---|---|
| HKW | Prism, Bar, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKW), ordered by most recent decision date.
View allOther Clearances by Roseburg SA
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| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |