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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Applicant
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510(K)
Number
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Decision
Date
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candela sclero long pulse laser (aka vbeam) CANDELA CORP. k013748 02/11/2002
endoanchor and openanchor ETHICON ENDO-SURGERY, INC. k013749 02/11/2002
advia 1650 cholinesterase assay BAYER DIAGNOSTICS CORP. k013750 01/18/2002
handheld gamma finder (hgf) SILICON INSTRUMENTS GMHB k013751 02/06/2002
compas as (computerized pulmonary analysis system) MORGAN SCIENTIFIC, INC. k013752 01/30/2002
disposable powder free vinyl synthetic exam gloves, white color CANOPUS MEDICAL SUPPLY CO., LTD. k013753 12/10/2001
concert radiopaque bone cement IMMEDICA, INC. k013755 02/08/2002
alphacor; alphacor-a (for ahakic eyes); alphacor-p (for phakic or pseudophakic eyes) ARGUS BIOMEDICAL PTY LTD k013756 08/29/2002
roche acetaminophen ROCHE DIAGNOSTICS CORP. k013757 01/08/2002
mss-28cs-301/701 needlescope OLYMPUS OPTICAL CO., LTD. k013759 08/20/2002

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