FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K Number: K953290
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
149
Review Days
85
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Basic Information
- Device Name
- OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
- K Number
- K953290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- July 14, 1995
- Decision Date
- October 7, 1995
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
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