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FDA 510(k), K001409, GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
FDA 510(k), K001409, GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
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510(K) Number: K001409
Device Name: GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
Manufacturer: HYPERBARIC TECHNOLOGIES, INC.
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 05/04/2000
Decision Date: 08/02/2000
Regulation Medical Specialty: Anesthesiology
Device Name: GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
Manufacturer: HYPERBARIC TECHNOLOGIES, INC.
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 05/04/2000
Decision Date: 08/02/2000
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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