FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERI-DENT, STERI-SURE
K Number: K094026
·
Decision Jul 12, 2011
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
5
Review Days
559
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Basic Information
- Device Name
- STERI-DENT, STERI-SURE
- K Number
- K094026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6870
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cpac, Inc.
- Date Received
- December 30, 2009
- Decision Date
- July 12, 2011
- Product Code
- KMH
- 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 |
|---|---|---|---|
| KMH | Sterilizer, Dry Heat | FDA class 2 | General Hospital |
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