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FDA 510(k), K911577, HYPOTRANS MODEL 750
FDA 510(k), K911577, HYPOTRANS MODEL 750
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510(K) Number: K911577
Device Name: HYPOTRANS MODEL 750
Manufacturer: DEBRA MCQUILLEN
Device Classification Name: Container, Transport, Kidney
Regulation Number: KDK
Classification Product Code: KXA
Date Received: 04/08/1991
Decision Date: 07/08/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HYPOTRANS MODEL 750
Manufacturer: DEBRA MCQUILLEN
Device Classification Name: Container, Transport, Kidney
Regulation Number: KDK
Classification Product Code: KXA
Date Received: 04/08/1991
Decision Date: 07/08/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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