FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOSITE UV INTERIM SPECTACLES
K Number: K823825
·
Decision Feb 24, 1983
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- NOSITE UV INTERIM SPECTACLES
- K Number
- K823825
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Patton, Boggs & Blow
- Date Received
- December 20, 1982
- Decision Date
- February 24, 1983
- 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 Patton, Boggs & Blow
| K Number | Device Name | ||
|---|---|---|---|
| K943348 | KLS CHIN PLATE SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K943346 | MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K943345 | MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K821799 | FITKIT I CHECKUP KIT | Aug 16, 1983 | Substantially Equivalent |