FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRU KLENZ
K Number: K935063
·
Decision May 9, 1994
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
18
Applicant Total
5
Review Days
200
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Basic Information
- Device Name
- INSTRU KLENZ
- K Number
- K935063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Calgon Corp.
- Date Received
- October 21, 1993
- Decision Date
- May 9, 1994
- Product Code
- FLG
- 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 |
|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | FDA class 1 | General Hospital |
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