FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
K Number: K133080
·
Decision Jun 24, 2015
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
2
Review Days
632
Basic Information
- Device Name
- Plus Surgical Drapes (EO Sterilized), PMDB-XXX
- K Number
- K133080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- FOSHAN NANHAI PLUS MEDICAL CO., LTD.
- Date Received
- September 30, 2013
- Decision Date
- June 24, 2015
- Product Code
- KKX
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by FOSHAN NANHAI PLUS MEDICAL CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | Jun 24, 2015 | Substantially Equivalent |