FDA 510(k) Application Details - K992107

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K992107
Device Name Vinyl Patient Examination Glove
Applicant GENERAL GLOVES CORP.
3423 INVESTMENT BLVD.
SUITE 12
HAYWARD, CA 94545 US
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Contact DAVID HU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 06/22/1999
Decision Date 08/23/1999
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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