FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpectraShield 9500 Surgical N95 Respirator
K Number: K150729
·
Decision Dec 29, 2015
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
3
Review Days
284
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Basic Information
- Device Name
- SpectraShield 9500 Surgical N95 Respirator
- K Number
- K150729
- 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
- Nexera Medical, Inc.
- Date Received
- March 20, 2015
- Decision Date
- December 29, 2015
- Product Code
- ONT
- 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 |
|---|---|---|---|
| ONT | N95 Respirator With Antimicrobial/Antiviral Agent | FDA class 2 | General, Plastic Surgery |
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