FDA 510(k) Application Details - K962999

Device Classification Name Syringe, Cartridge

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510(K) Number K962999
Device Name Syringe, Cartridge
Applicant INTEGRITECH, INC.
6020 BAYOU RD.
MOBILE, AL 36605 US
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Contact JERRY A SMITH
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Regulation Number 872.6770

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Classification Product Code EJI
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Date Received 08/02/1996
Decision Date 01/22/1997
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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