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FDA 510(k)

EMEM POWERED MEDIUM

K-Number: K820914 · 1982-04-21

Decision Date1982-04-21
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EMEM POWERED MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1982-04-21 under 510(k) number K820914. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMEM POWERED MEDIUM?

EMEM POWERED MEDIUM is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K820914.

When did EMEM POWERED MEDIUM receive FDA 510(k) clearance?

EMEM POWERED MEDIUM received FDA 510(k) clearance on 1982-04-21, under 510(k) number K820914.

Who is the listed applicant for EMEM POWERED MEDIUM?

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

What is the FDA product code for EMEM POWERED MEDIUM?

The FDA product code for EMEM POWERED MEDIUM is KIT.

Related Clinical Trials

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.

Other records listing Dutchland Laboratories, Inc. as applicant

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.

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Related Devices (Code: KIT)

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.

Official Source

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

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