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FDA 510(k) Application Details - K984249
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K984249
Device Name
Polymer Patient Examination Glove
Applicant
LONDON INTERNATIONAL GROUP, INC.
P.O. BOX 8308
2926 COLUMBIA HIGHWAY
DOTHAN, AL 36304 US
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Contact
NEIL ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
11/30/1998
Decision Date
05/04/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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