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FDA 510(k), K133957, DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
FDA 510(k), K133957, DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
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510(K) Number: K133957
Device Name: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
Manufacturer: GALEMED CORP.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 12/23/2013
Decision Date: 04/14/2014
Regulation Medical Specialty: Anesthesiology
Device Name: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
Manufacturer: GALEMED CORP.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 12/23/2013
Decision Date: 04/14/2014
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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