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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K954381
Device Name SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES
Applicant
Shanghai Poseidon Plastic Products Co., Ltd.
202 S. Route 31
Mchenry,  IL  60050
Applicant Contact ANTHONY L GIACCIO
Correspondent
Shanghai Poseidon Plastic Products Co., Ltd.
202 S. Route 31
Mchenry,  IL  60050
Correspondent Contact ANTHONY L GIACCIO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/19/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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