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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K062932
Device Name AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
Applicant
Ahlstrom Mount Holly Springs, LLC
122 W. Butler St.
Mount Holly Springs,  PA  17007
Applicant Contact HEATHER MOWERS
Correspondent
Ahlstrom Mount Holly Springs, LLC
122 W. Butler St.
Mount Holly Springs,  PA  17007
Correspondent Contact HEATHER MOWERS
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/28/2006
Decision Date 10/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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