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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|---|---|---|---|
| powder free (yellow) vinyl patient examination | SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L | k070044 |
01/29/2007 |
| sutralene polypropylene sutures | VISIONARY MEDICAL SUPPLIES, INC. | k070243 |
04/17/2007 |
| lumiloc (tm) safety introducer needle | SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. | k070449 |
06/14/2007 |
| architect stat troponin-1; myoglobin | FISHER DIAGNOSTICS | k070640 |
09/13/2007 |
| ulceloocin oral ulcer patch | SUNSHINE INTERNATIONAL GROUP, INC. | k070842 |
06/07/2007 |
| orthadapt bioimplant | PEGASUS BIOLOGICS, INC. | k071065 |
05/04/2007 |
| clirpath turbo excimer laser catheter (rx) -0.9mm, (rx) -1.4mm, (rx) -1.7mm, (rx) -2.0mm, model 310-154, 314-159, 317-15 | SPECTRANETICS CORP. | k071227 |
07/11/2007 |
| echoview / shimasonic diagnostic ultrasound system, model sdu-1100 | SHIMADZU MEDICAL SYSTEMS | k071291 |
01/09/2008 |
| endoscopic plication system; eps; plicator | NDO SURGICAL, INC. | k071553 |
09/18/2007 |
| aquadex flexflow system | CHF SOLUTIONS, INC. | k071854 |
09/07/2007 |
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