FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-SPONGE
K Number: K897034
·
Decision Feb 15, 1990
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
3
Review Days
59
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Basic Information
- Device Name
- K-SPONGE
- K Number
- K897034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Katena Products, Inc.
- Date Received
- December 18, 1989
- Decision Date
- February 15, 1990
- 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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