PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S— 510(k) K063013
Substantially EquivalentAearo Company
FDA 510(k) clearance K063013 for PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S, Substantially Equivalent on 2006-12-01. Applicant: Aearo Company. Device class: 2.
Clearance details
- Applicant
- Aearo Company
- Product code
- Code MSH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Southbridge, MA, US
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