510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
|
Decision
Date
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|---|---|---|---|
| stryker steri-shield surgical apparel | Stryker Corp. | k944393 |
08/28/1995 |
| w&h micro motor e25 (without light) | A-Dec, Inc. | k944712 |
08/25/1995 |
| life trace trans tip intrauterine pressure catheter | Graphic Controls Corp. | k950498 |
07/24/1995 |
| db push-pull hearing aid | Midwest City Hearing Aid Center | k953036 |
07/21/1995 |
| ticarcillin/clavulanic acid 2 | Ab Biodisk | k951879 |
07/07/1995 |
| elite biofeedback | Laborie Medical Technologies, Ltd. | k942563 |
06/06/1995 |
| jai | Intl. Trade Management Co. | k951513 |
05/25/1995 |
| harmony line kf | Ivoclar North America, Inc. | k951297 |
04/18/1995 |
| lasersonics surgical laser systems and accessories | Heraeus Surgical, Inc. | k943716 |
03/14/1995 |
| cobas(r)-fp reagents for gentamicin and cobas(r)-fp gentamicin calibrators | Roche Diagnostic Systems, Inc. | k945523 |
03/09/1995 |
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