FDA 510(k) Application Details - K960621

Device Classification Name Gauze, External (With Drug/Biologic/Animal Source Material)

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510(K) Number K960621
Device Name Gauze, External (With Drug/Biologic/Animal Source Material)
Applicant SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD, CO 80112 US
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Contact SARAH MAXWELL LAKE
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Regulation Number 000.0000

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Classification Product Code GER
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Date Received 02/13/1996
Decision Date 04/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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