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FDA 510(k), K101262, FLEXI-LITE
FDA 510(k), K101262, FLEXI-LITE
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510(K) Number: K101262
Device Name: FLEXI-LITE
Manufacturer: PRESSURE-TECH, INC.
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 05/05/2010
Decision Date: 06/10/2010
Regulation Medical Specialty: Anesthesiology
Device Name: FLEXI-LITE
Manufacturer: PRESSURE-TECH, INC.
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 05/05/2010
Decision Date: 06/10/2010
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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