FDA 510(k) Application Details - K971589

Device Classification Name Toothbrush, Manual

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510(K) Number K971589
Device Name Toothbrush, Manual
Applicant PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558 US
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Contact LORNA-JANE BREMER
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Regulation Number 872.6855

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Classification Product Code EFW
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Date Received 05/01/1997
Decision Date 07/24/1997
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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