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FDA 510(k), K972824, THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
FDA 510(k), K972824, THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
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510(K) Number: K972824
Device Name: THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
Manufacturer: PEGGY NICHOLSON
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: KXA
Date Received: 07/30/1997
Decision Date: 04/03/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
Manufacturer: PEGGY NICHOLSON
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: KXA
Date Received: 07/30/1997
Decision Date: 04/03/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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