FDA 510(k) Application Details - K893294

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K893294
Device Name Vinyl Patient Examination Glove
Applicant KING HANDY FIVE CORP.
17, KUNGCHU ROAD, FANYUAN
IND. DISTRICT
CHANGHUA 52804 TW
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Contact J. G WU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 04/18/1989
Decision Date 09/11/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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