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FDA 510(k) Application Details - K992162
Device Classification Name
Patient Examination Glove, Specialty
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510(K) Number
K992162
Device Name
Patient Examination Glove, Specialty
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
880.6250
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Classification Product Code
LZC
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More FDA Info for this Product Code
Date Received
06/25/1999
Decision Date
08/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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