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FDA 510(k) Application Details - K960292
Device Classification Name
Barrier, Synthetic, Intraoral
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510(K) Number
K960292
Device Name
Barrier, Synthetic, Intraoral
Applicant
W.L. GORE & ASSOCIATES,INC
1500 NORTH FOURTH ST.
FLAGSTAFF, AZ 86001 US
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Contact
JACQUELINE KALBACH
Other 510(k) Applications for this Contact
Regulation Number
872.3930
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Classification Product Code
NPK
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More FDA Info for this Product Code
Date Received
01/22/1996
Decision Date
04/15/1996
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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