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FDA 510(k)

AUDI-SIL EARMOLD MATERIAL

K-Number: K771615 · 1977-08-30

ApplicantCoe Laboratories, Inc.
Decision Date1977-08-30
Product CodeESH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDI-SIL EARMOLD MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1977-08-30 under 510(k) number K771615. The device is classified under product code ESH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDI-SIL EARMOLD MATERIAL?

AUDI-SIL EARMOLD MATERIAL is a medical device that received FDA 510(k) clearance on 1977-08-30. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K771615.

When did AUDI-SIL EARMOLD MATERIAL receive FDA 510(k) clearance?

AUDI-SIL EARMOLD MATERIAL received FDA 510(k) clearance on 1977-08-30, under 510(k) number K771615.

Who is the listed applicant for AUDI-SIL EARMOLD MATERIAL?

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

What is the FDA product code for AUDI-SIL EARMOLD MATERIAL?

The FDA product code for AUDI-SIL EARMOLD MATERIAL is ESH.

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Other records listing Coe 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.

K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK894281FIRST IMPRESSION WITH CHLORHEXIDINEK891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTK885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGK881422COE PAK AUTO MIX, REGULAR OR HARD SET

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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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