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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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barron twin blade trephine for eppikaratophakia Precision Instruments, Inc. k860648 03/25/1986
urotopo catheter Houston Biomedical, Inc. k861200 04/23/1986
angiographic catheter (cardiology & radiology) Mallinckrodt Critical Care k861483 05/15/1986
regan-lowe agar Gibco Laboratories Life Technologies, Inc. k861734 05/16/1986
quidel beta stick pregnancy test (modification) Quidel Corp. k862207 06/17/1986
biomedical dynamics disposable pressure infusor Biomedical Dynamics, Inc. k861977 07/15/1986
gnatus articulator 4.300/4.300gp 8.600 & ortoflex Sds Dental, Inc. k863009 09/25/1986
commview system A T & T Technologies, Inc. k862715 10/16/1986
sodium bicarbonate powder/bicarbonate hemodialysis American Healthcare Corp. k863631 10/16/1986
q101 diagnostic spirometer Quinton, Inc. k863300 11/13/1986

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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