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FDA 510(k) Application Details - K955749
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K955749
Device Name
Drape, Surgical
Applicant
FLYNT AMTEX, INC.
673 GILMER ST.
BURLINGTON, NC 27217 US
Other 510(k) Applications for this Company
Contact
JOHN A KRANASKAS
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/1995
Decision Date
11/22/1996
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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