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FDA 510(k) Application Details - K061242
Device Classification Name
Cover, Mattress (Medical Purposes)
More FDA Info for this Device
510(K) Number
K061242
Device Name
Cover, Mattress (Medical Purposes)
Applicant
PRECISION FABRICS GROUP, INC.
18 BRIDIE LANE
NORFOLK, MA 02056 US
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Contact
PAMELA J WEAGRAFF
Other 510(k) Applications for this Contact
Regulation Number
880.6190
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Classification Product Code
FMW
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More FDA Info for this Product Code
Date Received
05/03/2006
Decision Date
01/25/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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