FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SUNGLASS & SAFETY PLANO LENS
K Number: K822431
·
Decision Dec 27, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
137
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Basic Information
- Device Name
- SUNGLASS & SAFETY PLANO LENS
- K Number
- K822431
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Polycore Optical Pte , Ltd.
- Date Received
- August 12, 1982
- Decision Date
- December 27, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Polycore Optical Pte , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K832461 | POLYCORE | Aug 16, 1983 | Substantially Equivalent |
| K822542 | POLYCORE | Dec 27, 1982 | Substantially Equivalent |
| K822430 | KRYPTOX-ROUND SEGMENT BIFOCAL | Dec 27, 1982 | Substantially Equivalent |
| K822429 | SINGLE VISION POWER LENS | Dec 27, 1982 | Substantially Equivalent |
| K822541 | VISIOPAL 75 | Dec 27, 1982 | Substantially Equivalent |
| K790215 | LENS, POLYCORE | Feb 26, 1979 | Substantially Equivalent |