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FDA 510(k) Application Details - K001640
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K001640
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
BIOSOFT INTERNATIONAL CORP.
944 WILLIAMS ST.
TRENTON, NJ 08610 US
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Contact
ROY SHU
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Regulation Number
872.3760
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Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
05/08/2000
Decision Date
06/23/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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