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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
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karl storz endovision tricam, model 20221101 (20221001, pal format) color television camera for endoscopic procedures Karl Storz Imaging, Inc. k950862 05/24/1995
karl storz insulated scissors KARL STORZ Endoscopy-America, Inc. k944298 11/22/1994
coated zt proximal sleeve Joint Medical Products Corp. k934412 06/03/1994
delta-lite casting tape & splints Johnson & Johnson Professionals, Inc. k802522 01/08/1981
synthetic absorbable suture Johnson & Johnson International k944937 05/19/1995
serenity contoured absorbent shields Johnson & Johnson Consumer Products, Inc. k840679 03/22/1984
non-contact infrared thermometer Jinxinbao Electronic Co.,Ltd k130231 10/15/2013
arix foot system Jeil Medical Corporation k131311 09/05/2013
rd-2104 J.F. Jelenko & Co., Inc. k002222 08/31/2000
tri-scoot front wheel drive powered scooter Invacare Corp. k900600 02/20/1990

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