FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAC LAVE STEAM STERILIZER
K Number: K895275
·
Decision Nov 23, 1990
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
179
Applicant Total
1
Review Days
457
Basic Information
- Device Name
- MAC LAVE STEAM STERILIZER
- K Number
- K895275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- MERCHANTS EXPORT DEVELOPMENT CORP.
- Date Received
- August 23, 1989
- Decision Date
- November 23, 1990
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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