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FDA 510(k)

DRAINAGE BAG

K-Number: K990428 · 1999-08-12

ApplicantRemington Medical, Inc.
Decision Date1999-08-12
Product CodeEXF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K990428. The device is classified under product code EXF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAINAGE BAG?

DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Remington Medical, Inc.. The 510(k) number is K990428.

When did DRAINAGE BAG receive FDA 510(k) clearance?

DRAINAGE BAG received FDA 510(k) clearance on 1999-08-12, under 510(k) number K990428.

Who is the listed applicant for DRAINAGE BAG?

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

What is the FDA product code for DRAINAGE BAG?

The FDA product code for DRAINAGE BAG is EXF.

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Other records listing Remington Medical, Inc. as applicant

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Related Devices (Code: EXF)

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.

K003078MERIT DRAINAGE DEPOTMerit Medical Systems, Inc.K980005MANAN D BAGMedical Device Technologies, Inc.K961986MANAN D BAGManan Medical Products, Inc.K963849MANAN D BAGManan Medical Products, Inc.K943663NAVARRE 600 ML DRAINAGE BAGNavarre Biomedical , Ltd.K911129MMG BILE BAGMedical Technologies of Georgia

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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