FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Pivot System Sterilization case
K Number: K181845
·
Decision Nov 25, 2019
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
1
Review Days
502
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Basic Information
- Device Name
- Pivot System Sterilization case
- K Number
- K181845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rp Medical, Inc.
- Date Received
- July 11, 2018
- Decision Date
- November 25, 2019
- Product Code
- KCT
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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