FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
CareGUARD Sterilization Wrap
K Number: K213907
·
Decision Mar 14, 2022
Classifications
1
FEI Numbers
203
Registration Numbers
203
Same Product Code
316
Applicant Total
3
Review Days
90
Basic Information
- Device Name
- CareGUARD Sterilization Wrap
- K Number
- K213907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Care Essentials Pty Ltd
- Date Received
- December 14, 2021
- Decision Date
- March 14, 2022
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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