FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GFB-B CONTACT LENS BLANKS
K Number: K822315
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
3
Review Days
105
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Basic Information
- Device Name
- GFB-B CONTACT LENS BLANKS
- K Number
- K822315
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Hamel, Park, Mccabe & Saunders
- Date Received
- August 3, 1982
- Decision Date
- November 16, 1982
- 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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