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FDA 510(k) Application Details - K955872
Device Classification Name
Drape, Surgical
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510(K) Number
K955872
Device Name
Drape, Surgical
Applicant
MEDAL INTL. SALES CO., LLC.
100 EAST 15TH ST.
SUITE 320
FT. WORTH, TX 76102 US
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Contact
RICHARD A HAMER
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Regulation Number
878.4370
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Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
12/28/1995
Decision Date
03/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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