FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Medical Surgical Gowns
K Number: K202844
·
Decision Jan 6, 2021
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
7
Review Days
103
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Basic Information
- Device Name
- Medical Surgical Gowns
- K Number
- K202844
- 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
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- Date Received
- September 25, 2020
- Decision Date
- January 6, 2021
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231513 | Oral Matrix | Feb 16, 2024 | Substantially Equivalent |
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| K202029 | Medical Surgical Mask | Dec 16, 2020 | Substantially Equivalent |
| K201641 | Disposable Laparoscope Trocar | Aug 6, 2020 | Substantially Equivalent |
| K201243 | Disposable Specimen Retrieval Bag | Jul 10, 2020 | Substantially Equivalent |