FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K Number: K861825
·
Decision Jun 9, 1986
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
11
Applicant Total
101
Review Days
28
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Basic Information
- Device Name
- CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
- K Number
- K861825
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Storz Instrument Co.
- Date Received
- May 12, 1986
- Decision Date
- June 9, 1986
- Product Code
- HRH
- 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 |
|---|---|---|---|
| HRH | Trephine, Manual, Ophthalmic | FDA class 1 | Ophthalmic |
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