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FDA 510(k), K905168, HYPERLITE
FDA 510(k), K905168, HYPERLITE
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510(K) Number: K905168
Device Name: HYPERLITE
Manufacturer: SELBY
Device Classification Name: Chamber, Hyperbaric
Regulation Number: CBF
Classification Product Code: KXA
Date Received: 11/16/1990
Decision Date: 07/22/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: HYPERLITE
Manufacturer: SELBY
Device Classification Name: Chamber, Hyperbaric
Regulation Number: CBF
Classification Product Code: KXA
Date Received: 11/16/1990
Decision Date: 07/22/1991
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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