FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STORS SCLERAL SPONGE II (LINCOFF DESIGN)
K Number: K950599
·
Decision Mar 2, 1995
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- STORS SCLERAL SPONGE II (LINCOFF DESIGN)
- K Number
- K950599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Ophthalmics, Inc.
- Date Received
- February 9, 1995
- Decision Date
- March 2, 1995
- Product Code
- HQX
- 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 |
|---|---|---|---|
| HQX | Implant, Orbital, Extra-Ocular | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQX), ordered by most recent decision date.
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Other Clearances by Storz Ophthalmics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884060 | MEDITEC QL-15 ND:YAG LASER | Nov 4, 1988 | Substantially Equivalent |