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FDA 510(k) Application Details - K962724
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K962724
Device Name
Surgeon'S Gloves
Applicant
SONNHEIM MEDIKAL GMBH
ERNST THALMANN ALLEE 37
ZEULENRODA 07937 DE
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Contact
ANIL SEGAT
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/1996
Decision Date
10/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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