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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 K944514
Device Name P2 NITRILE EXAM GLOVES
Applicant
Biosafety Systems, Inc.
10255 Willow Creek Rd.
San Diego,  CA  92131
Applicant Contact BILL HOWES
Correspondent
Biosafety Systems, Inc.
10255 Willow Creek Rd.
San Diego,  CA  92131
Correspondent Contact BILL HOWES
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/15/1994
Decision Date 11/28/1994
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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