FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
K Number: K980109
·
Decision Aug 18, 1998
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
10
Applicant Total
3
Review Days
218
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Basic Information
- Device Name
- CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
- K Number
- K980109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6430
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sangstat Medical Corp.
- Date Received
- January 12, 1998
- Decision Date
- August 18, 1998
- Product Code
- KYX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KYX | Dispenser, Liquid Medication | FDA class 1 | General Hospital |
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