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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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modification to blue sky dental implant system BLUE SKY BIO k021833 06/10/2002
modification to alpha dx system FIRST MEDICAL, INC. k013118 10/15/2001
model iii handswitch SARA DAN, INC. k792600 01/10/1980
model 900 photocoagulator with green-only options COHERENT RADIATION LABORATORIES k827383 11/23/1982
model 833hc vacuum/gravity steam sterilizer GETINGE USA, INC k031259 05/12/2003
model 733hc gravity/vacuum steam sterilizer GETINGE/CASTLE, INC. k020590 03/20/2002
mod. 9542 flow-thru inject. temp. sensor EDWARDS LABORATORIES k801552 07/28/1980
mist ic Imagine Milling Technologies, LLC k222368 12/01/2022
microcatheter NAVILYST MEDICAL, INC. k112124 08/19/2011
meg-2b blood glucose monitoring system, pro blood glucose monitoring system, blood glucose test strips, glucose control APEX BIOTECHNOLOGY CORP. k120448 04/06/2012

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