FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OPTOCRYL CONTACT LENS BLANKS
K Number: K810130
·
Decision Jun 11, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
4
Review Days
143
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Basic Information
- Device Name
- OPTOCRYL CONTACT LENS BLANKS
- K Number
- K810130
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Optacryl, Inc.
- Date Received
- January 19, 1981
- Decision Date
- June 11, 1981
- Product Code
- HPX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |
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