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FDA 510(k) Application Details - K042145
Device Classification Name
Bedding, Disposable, Medical
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510(K) Number
K042145
Device Name
Bedding, Disposable, Medical
Applicant
TECHTRADE LLC
11900 GAINSBOROUGH ROAD
P.O.BOX 2005
POTOMAC, MD 20854-3305 US
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Contact
ARTHUR M HOROWITZ
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Regulation Number
880.6060
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Classification Product Code
KME
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More FDA Info for this Product Code
Date Received
08/09/2004
Decision Date
09/17/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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