FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CONCENTRATED CLEANER FOR HARD CONTACTS
K Number: K820818
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
92
Review Days
16
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Basic Information
- Device Name
- CONCENTRATED CLEANER FOR HARD CONTACTS
- K Number
- K820818
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- March 24, 1982
- Decision Date
- April 9, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPX), ordered by most recent decision date.
PMMA CLASIC
FDA 510(k)
FDA Unclassified
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KERATOPLASTY SUTURING LENS
FDA 510(k)
FDA Unclassified
·Unknown
MULTI-VIEW BIFOCALS
FDA 510(k)
FDA Unclassified
·Unknown
MARTIN-HENSLEY SEGMENT LENS
FDA 510(k)
FDA Unclassified
·Unknown
OPTIKEM PMMA CONTACT LENS
FDA 510(k)
FDA Unclassified
·Unknown
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
FDA 510(k)
FDA Unclassified
·Unknown
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| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Oct 25, 2011 | Substantially Equivalent |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Aug 17, 2010 | Substantially Equivalent |