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FDA 510(k)

REDYROB-CLOSED WOUND DRAINAGE SYSTEM

K-Number: K972703 · 1997-10-01

ApplicantB.Braun Medical, Inc.
Decision Date1997-10-01
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REDYROB-CLOSED WOUND DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K972703. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDYROB-CLOSED WOUND DRAINAGE SYSTEM?

REDYROB-CLOSED WOUND DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K972703.

When did REDYROB-CLOSED WOUND DRAINAGE SYSTEM receive FDA 510(k) clearance?

REDYROB-CLOSED WOUND DRAINAGE SYSTEM received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972703.

Who is the listed applicant for REDYROB-CLOSED WOUND DRAINAGE SYSTEM?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDYROB-CLOSED WOUND DRAINAGE SYSTEM?

The FDA product code for REDYROB-CLOSED WOUND DRAINAGE SYSTEM is GCY.

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Related Devices (Code: GCY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.K930615AUTOVAC CLOSED WOUND SUCTION SYSTEMBoehringer Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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