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FDA 510(k), K010659, SEA-LONG MEDICAL TREATMENT HOOD
FDA 510(k), K010659, SEA-LONG MEDICAL TREATMENT HOOD
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510(K) Number: K010659
Device Name: SEA-LONG MEDICAL TREATMENT HOOD
Manufacturer: GERALD COX
Device Classification Name: Chamber, Hyperbaric
Regulation Number: CBF
Classification Product Code: KXA
Date Received: 03/06/2001
Decision Date: 05/16/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: SEA-LONG MEDICAL TREATMENT HOOD
Manufacturer: GERALD COX
Device Classification Name: Chamber, Hyperbaric
Regulation Number: CBF
Classification Product Code: KXA
Date Received: 03/06/2001
Decision Date: 05/16/2001
Decision: Substantially Equivalent (SESE)
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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