Atlas FDA

HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810

FDA 510(k) clearance K080827 · decided 2008-04-04

Clearance details

K-number
K080827
Device name
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
Applicant
Handan Hengyong Protective & Clean Products Co., L
Decision
Substantially Equivalent
Date received
2008-03-25
Decision date
2008-04-04
Days to decision
10 days
Clearance type
Abbreviated
Product code
MSH
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Shijiazhuang, Hebei Province, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.