FDA 510(k) Application Details - K971794

Device Classification Name Device, Anti-Snoring

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510(K) Number K971794
Device Name Device, Anti-Snoring
Applicant FRANTZ DESIGN, INC.
400 MEDICAL CENTER, #209
WEBSTER, TX 77598 US
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Contact DONALD FRANTZ
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 05/15/1997
Decision Date 09/29/1997
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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