FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CHIROFLEX II LENS MICROSERT(TM)
K Number: K914311
·
Decision Jan 27, 1992
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
4
Applicant Total
10
Review Days
123
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Basic Information
- Device Name
- CHIROFLEX II LENS MICROSERT(TM)
- K Number
- K914311
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chiron Ophthalmics
- Date Received
- September 26, 1991
- Decision Date
- January 27, 1992
- Product Code
- HQL
- 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 |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |
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Other Clearances by Chiron Ophthalmics
| K Number | Device Name | ||
|---|---|---|---|
| K915861 | MEDILENS-CS CORNEAL SHIELD | Mar 6, 1992 | Substantially Equivalent |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Jun 10, 1991 | Substantially Equivalent |
| K903575 | CHIROFLEX FORCEPS | Dec 21, 1990 | Substantially Equivalent |
| K903574 | CHIROFLEX LENS MICROSERT | Sep 17, 1990 | Substantially Equivalent |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Jul 2, 1990 | Substantially Equivalent |
| K894162 | OPTISOL | Jan 12, 1990 | Substantially Equivalent |
| K885015 | COI 72 HR COLLAGEN SHIELD | Jun 23, 1989 | Substantially Equivalent |
| K885016 | COI 24 HR COLLAGEN SHIELD | Feb 1, 1989 | Substantially Equivalent |
| K882762 | COLLAGEN SHIELD | Sep 12, 1988 | Substantially Equivalent |