FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDILENS-CS CORNEAL SHIELD
K Number: K915861
·
Decision Mar 6, 1992
Classifications
1
FEI Numbers
11
Registration Numbers
12
Same Product Code
18
Applicant Total
10
Review Days
66
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Basic Information
- Device Name
- MEDILENS-CS CORNEAL SHIELD
- K Number
- K915861
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Ophthalmics
- Date Received
- December 31, 1991
- Decision Date
- March 6, 1992
- Product Code
- MOE
- 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 |
|---|---|---|---|
| MOE | Collagen Corneal Shield | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOE), ordered by most recent decision date.
BIO-COR COLLAGEN CORNEAL SHIELD
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SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
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FDA Class 1
·Ophthalmic
COLLAGEN SHIELD FOR ACUTE CARE
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FDA Class 1
·Ophthalmic
COLLAGEN SHIELD, VARIOUS MODELS
FDA 510(k)
FDA Class 1
·Ophthalmic
COLLAGEN SHIELD FOR ACUTE CARE
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDILENS(TM) CORNEAL SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Chiron Ophthalmics
| K Number | Device Name | ||
|---|---|---|---|
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | Jan 27, 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 |