FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHSIGHT LENSES WITH ZUMA COATING
K Number: K772044
·
Decision Nov 9, 1977
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
2
Review Days
12
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Basic Information
- Device Name
- TECHSIGHT LENSES WITH ZUMA COATING
- K Number
- K772044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Techsight Corp.
- Date Received
- October 28, 1977
- Decision Date
- November 9, 1977
- 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 Techsight Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K772124 | LENSES, EYEGLASS, SAFETY | Nov 16, 1977 | Substantially Equivalent |