FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENT WIPE AND CORNEAL SHIELD
K Number: K912576
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
3
Review Days
233
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSTRUMENT WIPE AND CORNEAL SHIELD
- K Number
- K912576
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Katena Products, Inc.
- Date Received
- June 12, 1991
- Decision Date
- January 31, 1992
- Product Code
- HOY
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOY), ordered by most recent decision date.
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
FDA 510(k)
FDA Class 1
·Ophthalmic
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
FDA 510(k)
FDA Class 1
·Ophthalmic
ARCTIC PREMIER SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
GOGGLE SAFEGUARD
FDA 510(k)
FDA Class 1
·Ophthalmic
SHIELD, EYE, OPHTHALMIC
FDA 510(k)
FDA Class 1
·Ophthalmic