FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K Number: K921106
·
Decision Mar 30, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
38
Applicant Total
101
Review Days
21
Basic Information
- Device Name
- STERILE/SINGLE USE EYE SPHERE IMPLANTS
- K Number
- K921106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STORZ INSTRUMENT CO.
- Date Received
- March 9, 1992
- Decision Date
- March 30, 1992
- Product Code
- HPZ
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
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