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FDA 510(k) Application Details - K981808
Device Classification Name
Scraper, Tongue
More FDA Info for this Device
510(K) Number
K981808
Device Name
Scraper, Tongue
Applicant
BREATHAID, LLC.
KEENAN BLDG., 3RD FLOOR
1330 LADY STREET
COLUMBIA, SC 29211 US
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Contact
J. DOUGLAS NUNN, JR.
Other 510(k) Applications for this Contact
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
05/21/1998
Decision Date
08/11/1998
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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