FDA 510(k) Application Details - K984249

Device Classification Name Polymer Patient Examination Glove

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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
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Regulation Number 880.6250

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Classification Product Code LZA
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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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