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FDA 510(k) Application Details - K991317
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K991317
Device Name
Surgeon'S Gloves
Applicant
SAFESKIN CORP.
12671 HIGH BLUFF DR.
SAN DIEGO, CA 92130 US
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Contact
EUGENE V GOORCHENKO
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
04/19/1999
Decision Date
05/21/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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