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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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
GER
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More FDA Info for this Product Code
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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