FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Self Sealing Sterilization Pouches
K Number: K243721
·
Decision Apr 25, 2025
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
3
Review Days
143
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Basic Information
- Device Name
- Self Sealing Sterilization Pouches
- K Number
- K243721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wellmed Dental Medical Supply Co., Ltd.
- Date Received
- December 3, 2024
- Decision Date
- April 25, 2025
- 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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