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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 K891726
Device Name VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
Applicant
Baldur Systems Corp.
3423 Investment Blvd., #12
Hayward,  CA  94545
Applicant Contact DAVID HU
Correspondent
Baldur Systems Corp.
3423 Investment Blvd., #12
Hayward,  CA  94545
Correspondent Contact DAVID HU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/23/1989
Decision Date 05/12/1989
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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