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FDA 510(k)

EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION

K-Number: K850526 · 1985-02-27

ApplicantMediatech, Inc.
Decision Date1985-02-27
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850526. 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 EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION?

EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Mediatech, Inc.. The 510(k) number is K850526.

When did EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION receive FDA 510(k) clearance?

EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850526.

Who is the listed applicant for EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION?

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

What is the FDA product code for EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION?

The FDA product code for EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION is KIT.

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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.

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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.

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