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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|---|---|---|---|
| s30/s40 digital color doppler ultraound system | SONOSCAPE COMPANY LIMITED | k150045 |
04/28/2015 |
| 4cis peek, plif and tlif cage system | SOLCO BIOMEDICAL CO., LTD. | k092162 |
01/06/2010 |
| sol-guard safety pull button collection set | Sol-Millennium Medical, Inc. | k213718 |
08/30/2022 |
| sodem high speed system (electric) (general orthopedics & plastic surgery) | SODEM SYSTEMS | k012453 |
10/22/2001 |
| zirconia ceramic femoral head - 12/14 taper | SMITH & NEPHEW, INC. | k013989 |
12/19/2001 |
| handheld gamma finder (hgf) | SILICON INSTRUMENTS GMHB | k013751 |
02/06/2002 |
| monopoly pedicle screw system | SIGNUS MEDICAL LLC. | k081108 |
07/14/2008 |
| procedure #430 & reagents for acetamin | SIGMA CHEMICAL CO. | k822313 |
08/24/1982 |
| sientra opus silicone gel breast implant sizer | Sientra, Inc | k200706 |
11/16/2020 |
| somatom p30 ct systems | SIEMENS MEDICAL SYSTEMS, INC. | k013522 |
11/07/2001 |
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