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FDA 510(k), K844630, ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
FDA 510(k), K844630, ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
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510(K) Number: K844630
Device Name: ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
Manufacturer: ORGANON TEKNIKA CORP.
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 11/27/1984
Decision Date: 03/12/1985
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
Manufacturer: ORGANON TEKNIKA CORP.
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 11/27/1984
Decision Date: 03/12/1985
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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