FDA 510(k) Application Details - K071578

Device Classification Name

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510(K) Number K071578
Device Name BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
Applicant LIFESCIENCE PLUS, INC.
22 STONY HILL DRIVE
MYSTIC, CT 06355 US
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Contact AUDREY VITALE
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Regulation Number

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Classification Product Code QSY
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Date Received 06/08/2007
Decision Date 09/27/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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