FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILEMAX
K Number: K953938
·
Decision Jan 30, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
2
Review Days
528
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Basic Information
- Device Name
- STERILEMAX
- K Number
- K953938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barnstead/Thermolyne Corp.
- Date Received
- August 21, 1995
- Decision Date
- January 30, 1997
- 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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Other Clearances by Barnstead/Thermolyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K014174 | HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 | Feb 22, 2002 | Substantially Equivalent |