FDA Registration
Active
🇺🇸 United States
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
Reg #: 3014421917
·
FEI: 3014421917
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- O&M Halyard, Inc.
- Registration Number
- 3014421917
- FEI Number
- 3014421917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K974068
Owner / Operator
- Firm Name
- O&M Halyard, Inc.
- Operator Number
- 10057479
- Address
- 1220 Old Alpharetta Rd, Suite 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela Bunn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
Proprietary Names
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198