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510(k) Data Aggregation
K Number
K111559Device Name
SURGICAL MASKS
Manufacturer
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
Date Cleared
2011-09-16
(102 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**SHANGHAI NEO-MEDICAL IMPORT **& EXPORT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
Device Description
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description.
All of the proposed devices are non-sterile, and only for single use.
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