FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER ENCORE STERILIZER
K Number: K962755
·
Decision Mar 4, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
124
Review Days
231
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Basic Information
- Device Name
- STRYKER ENCORE STERILIZER
- K Number
- K962755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stryker Corp.
- Date Received
- July 16, 1996
- Decision Date
- March 4, 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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