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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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swiss lithoclast multipurpose probe ELECTRO MEDICAL SYSTEMS SA k992251 07/27/1999
surgisis sling COOK BIOTECH, INC. k992159 09/23/1999
surgical drape kit - d.i.r.r.a. srl D.I.R.R.A. S.R.L. k041080 11/30/2004
suni max SATELEC k000049 04/04/2000
steripack sterile disposable syringe & sterile disposable insulin syringe ATLANTIC PRODUCTS, INC. k023108 12/03/2002
sterile powder free latex surgeon gloves with protein labeling claim (50 microgram or less) SUPERMAX GLOVE MANUFACTURING SDN BHD k014230 03/13/2002
stephens disposable speculum STEPHENS INSTRUMENTS k022836 11/01/2002
status stik, accusign stik PRINCETON BIOMEDITECH CORP. k992068 07/06/1999
stat-shell disposable spo2 sensor EPIC MEDICAL EQUIPMENT SERVICES, INC. k992092 12/22/1999
stars2000 power cannula KMI KOLSTER METHODS, INC. k012236 11/19/2001

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