FDA 510(k) Application Details - K962837

Device Classification Name Surgeon'S Gloves

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510(K) Number K962837
Device Name Surgeon'S Gloves
Applicant MED-TECH RUBBER & ENGINEERING INDUSTRIES
B-4/5 BYCULLA SERVICE
INDUSTRIES PREMISES
SUSSEX RAD, YCULLA, 400027 IN
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Contact YOGESH R SHAH
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 07/09/1996
Decision Date 10/02/1996
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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