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FDA 510(k) Application Details - K981823
Device Classification Name
Drape, Surgical
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510(K) Number
K981823
Device Name
Drape, Surgical
Applicant
BALDUR SYSTEMS CORP.
25 HERITAGE DR.
ASHEVILLE, NC 28806 US
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Contact
STEVE WOODY
Other 510(k) Applications for this Contact
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
05/22/1998
Decision Date
08/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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