FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K Number: K011191
·
Decision Jun 26, 2001
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
37
Review Days
68
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Basic Information
- Device Name
- MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
- K Number
- K011191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed, Inc.
- Date Received
- April 19, 2001
- Decision Date
- June 26, 2001
- Product Code
- HOZ
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
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