FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CCI CORNEAL SCARIFIER
K Number: K904505
·
Decision Apr 23, 1991
Classifications
1
FEI Numbers
161
Registration Numbers
161
Same Product Code
25
Applicant Total
111
Review Days
203
Basic Information
- Device Name
- CCI CORNEAL SCARIFIER
- K Number
- K904505
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- BUCKMAN CO., INC.
- Date Received
- October 2, 1990
- Decision Date
- April 23, 1991
- Product Code
- GDX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDX | Scalpel, One-Piece | FDA class 1 | General, Plastic Surgery |
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