FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CHARTER LABORATORIES INC. LENS LUBRICANT
K Number: K863974
·
Decision Nov 10, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- CHARTER LABORATORIES INC. LENS LUBRICANT
- K Number
- K863974
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Paco Pharmaceutical Services, Inc.
- Date Received
- October 14, 1986
- Decision Date
- November 10, 1986
- 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
·Unknown
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
Other Clearances by Paco Pharmaceutical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Jan 20, 1987 | Substantially Equivalent |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Sep 25, 1986 | Substantially Equivalent |
| K843797 | STERILE SALINE SOLUTION | Jan 18, 1985 | Substantially Equivalent |
| K843796 | STERILE WATER | Dec 10, 1984 | Substantially Equivalent |
| K761093 | BANDAGE | Jan 6, 1977 | Substantially Equivalent |