FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medline Non-Surgical Isolation Gown-
K Number: K160471
·
Decision Jan 31, 2017
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
67
Applicant Total
165
Review Days
347
Basic Information
- Device Name
- Medline Non-Surgical Isolation Gown-
- K Number
- K160471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDLINE INDUSTRIES, INC.
- Date Received
- February 19, 2016
- Decision Date
- January 31, 2017
- Product Code
- FYC
- 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | FDA class 2 | General, Plastic Surgery |
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