FDA 510(k) Application Details - K080466

Device Classification Name

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510(K) Number K080466
Device Name ALCOHOL PAD
Applicant 122 CORPORATION
3525 DEL MAR HEIGHTS
SUITE 430
SAN DIEGO, CA 92130 US
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Contact DONALD CANAL
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Regulation Number

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Classification Product Code QBP
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Date Received 02/21/2008
Decision Date 10/21/2008
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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