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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K883244
Device Name PRISTINE XTRA, SURGEON'S GLOVE
Applicant
Japan World Medical Supply
4340 Stevens Creek Blvd.
Suite 110
San Jose,  CA  95129
Applicant Contact PAULA TERRELL
Correspondent
Japan World Medical Supply
4340 Stevens Creek Blvd.
Suite 110
San Jose,  CA  95129
Correspondent Contact PAULA TERRELL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/02/1988
Decision Date 08/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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