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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 K922968
Device Name VINYL EXAM GLOVES
Applicant
Normandin Pacific Holdings Corp.
25834 Cypress Ave.
Lomita,  CA  90717
Applicant Contact ROBERT C MATTICE
Correspondent
Normandin Pacific Holdings Corp.
25834 Cypress Ave.
Lomita,  CA  90717
Correspondent Contact ROBERT C MATTICE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/19/1992
Decision Date 01/27/1993
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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