FDA 510(k)

HEAVY DRAINAGE PACK

K-Number: K803116 · 1981-01-28

ApplicantAmerican Medical Disposable, Inc.

Decision Date1981-01-28

Product CodeGEC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEAVY DRAINAGE PACK is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K803116. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAVY DRAINAGE PACK?

HEAVY DRAINAGE PACK is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K803116.

When did HEAVY DRAINAGE PACK receive FDA 510(k) clearance?

HEAVY DRAINAGE PACK received FDA 510(k) clearance on 1981-01-28, under 510(k) number K803116.

Who is the listed applicant for HEAVY DRAINAGE PACK?

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

What is the FDA product code for HEAVY DRAINAGE PACK?

The FDA product code for HEAVY DRAINAGE PACK is GEC.

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Other records listing American Medical Disposable, Inc. as applicant

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Related Devices (Code: GEC)

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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.