FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K Number: K160337
·
Decision Jul 7, 2017
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
1
Review Days
515
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Basic Information
- Device Name
- Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
- K Number
- K160337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bam Corporation Limited
- Date Received
- February 8, 2016
- Decision Date
- July 7, 2017
- Product Code
- QPC
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | FDA class 2 | General, Plastic Surgery |
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