FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER
K Number: K950341
·
Decision Apr 19, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
1
Review Days
82
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Basic Information
- Device Name
- BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER
- K Number
- K950341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Barnard and Assoc.
- Date Received
- January 27, 1995
- Decision Date
- April 19, 1995
- 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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