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FDA 510(k) Application Details - K030445
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K030445
Device Name
Surgeon'S Gloves
Applicant
PRIMUS GLOVES PRIVATE LTD.
14-A, COCHIN SPECIAL ECONOMIC
ZONE
KAKKANAD, COCHIN, KERALA 682037 IN
Other 510(k) Applications for this Company
Contact
JOSEPH J.E. PEREIRA
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
02/11/2003
Decision Date
06/05/2003
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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