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FDA 510(k)

ECHO GEL (RAINFOREST)

K-Number: K895100 · 1989-11-03

ApplicantLead-Lok, Inc.
Decision Date1989-11-03
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHO GEL (RAINFOREST) is the device name listed in this FDA 510(k) record. The listed applicant is Lead-Lok, Inc.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K895100. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO GEL (RAINFOREST)?

ECHO GEL (RAINFOREST) is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Lead-Lok, Inc.. The 510(k) number is K895100.

When did ECHO GEL (RAINFOREST) receive FDA 510(k) clearance?

ECHO GEL (RAINFOREST) received FDA 510(k) clearance on 1989-11-03, under 510(k) number K895100.

Who is the listed applicant for ECHO GEL (RAINFOREST)?

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

What is the FDA product code for ECHO GEL (RAINFOREST)?

The FDA product code for ECHO GEL (RAINFOREST) is ITX.

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Other records listing Lead-Lok, 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: ITX)

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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