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FDA 510(k) Application Details - K973424
Device Classification Name
Scraper, Tongue
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510(K) Number
K973424
Device Name
Scraper, Tongue
Applicant
ENFRESH PRODUCTS LLC.
555 13TH STREET, NW.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN, ESG
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Regulation Number
872.6855
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Classification Product Code
LCN
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More FDA Info for this Product Code
Date Received
09/10/1997
Decision Date
12/09/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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