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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|---|---|---|---|
| quick chem ii | Seradyn, Inc. | k901695 |
05/24/1990 |
| sensormedics oxyshuttle(tm) | Sensor Medics Corp. | k862617 |
09/26/1986 |
| full auto blood pressure monitor, model se-7700h | Sein Electronics Co., Ltd. | k003282 |
11/01/2000 |
| modified peripheral dilatation catheters | Schneider-Shilley (Usa) | k875175 |
07/28/1988 |
| bores* adjustable blade holder | Santa Barbara Medco, Inc. | k812070 |
08/18/1981 |
| sandare bcg albumin procedure | Sandare Chemical Co., Inc. | k860684 |
03/17/1986 |
| san up s.a. nebulizer compressor, with disposable nebulizer, model 3050 | San UP S.A. | k002468 |
03/02/2001 |
| kestrel contact lens storage case(noryl) | Ryder Intl. Corp. | k853728 |
12/13/1985 |
| rxsight® insertion device | Rxsight, Inc. | k261174 |
06/10/2026 |
| elecsys b-crosslaps calcheck | Roche Diagnostics Corp. | k000042 |
03/17/2000 |
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