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FDA 510(k)

DYNACOR STERILE CLOSED SYS. DRAINAGE BAG

K-Number: K791969 · 1979-11-05

ApplicantMedline Industries, Inc.
Decision Date1979-11-05
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNACOR STERILE CLOSED SYS. DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791969. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNACOR STERILE CLOSED SYS. DRAINAGE BAG?

DYNACOR STERILE CLOSED SYS. DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Medline Industries, Inc.. The 510(k) number is K791969.

When did DYNACOR STERILE CLOSED SYS. DRAINAGE BAG receive FDA 510(k) clearance?

DYNACOR STERILE CLOSED SYS. DRAINAGE BAG received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791969.

Who is the listed applicant for DYNACOR STERILE CLOSED SYS. DRAINAGE BAG?

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

What is the FDA product code for DYNACOR STERILE CLOSED SYS. DRAINAGE BAG?

The FDA product code for DYNACOR STERILE CLOSED SYS. DRAINAGE BAG is KNX.

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Other records listing Medline Industries, Inc. as applicant

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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