FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
K Number: K874411
·
Decision Jan 27, 1988
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
16
Applicant Total
60
Review Days
91
Basic Information
- Device Name
- DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
- K Number
- K874411
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4440
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- October 28, 1987
- Decision Date
- January 27, 1988
- Product Code
- HMP
- 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 |
|---|---|---|---|
| HMP | Pad, Eye | FDA class 1 | General, Plastic Surgery |
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