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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|---|---|---|---|
| pmh 5000 heated humidifier for respiratory therapy | PEGASUS RESEARCH CORP. | k020700 |
04/26/2004 |
| syncrus internal cardioversion system | GUIDANT CORPORATION, CARDIAC SURGERY | k020701 |
05/24/2002 |
| o'regan disposable anoscope | CANADIAN THEATRE PRODUCTS LTD. | k020702 |
03/29/2002 |
| scorpio cr and ps co cr femoral components with titanium plasma spray coating | HOWMEDICA OSTEONICS CORP. | k020703 |
11/13/2002 |
| roche online gentamicin | ROCHE DIAGNOSTICS CORP. | k020704 |
07/12/2002 |
| siis#1 tissue suspension system | TAG MEDICAL PRODUCTS | k020705 |
04/26/2002 |
| ebv-vca igg elisa test, model ebg-100 | PAN BIO PTY. LTD. | k020706 |
06/13/2002 |
| ebv-ebna igg elisa kit, model ebg-100 | PAN BIO PTY. LTD. | k020707 |
06/13/2002 |
| purtian bennett, good knight 420g model m-113900-us; purtan bennett, goodknight 420s model m-113903-us | TYCO HEALTHCARE NANCY | k020886 |
11/01/2002 |
| ebi ais spine system | EBI, L.P. | k020887 |
05/16/2002 |
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