FDA 510(k) Application Details - K972026

Device Classification Name Scaler, Ultrasonic

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510(K) Number K972026
Device Name Scaler, Ultrasonic
Applicant SATELEC
70 WALNUT ST.
WELLESLEY, MA 02481 US
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Contact JACKIE MASSE
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 06/02/1997
Decision Date 07/09/1997
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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