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FDA 510(k)

PRECISE IMPRESSION KIT

K-Number: K970952 · 1997-05-02

ApplicantStarkey Laboratories, Inc.
Decision Date1997-05-02
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PRECISE IMPRESSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1997-05-02 under 510(k) number K970952. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISE IMPRESSION KIT?

PRECISE IMPRESSION KIT is a medical device that received FDA 510(k) clearance on 1997-05-02. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K970952.

When did PRECISE IMPRESSION KIT receive FDA 510(k) clearance?

PRECISE IMPRESSION KIT received FDA 510(k) clearance on 1997-05-02, under 510(k) number K970952.

Who is the listed applicant for PRECISE IMPRESSION KIT?

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

What is the FDA product code for PRECISE IMPRESSION KIT?

The FDA product code for PRECISE IMPRESSION KIT is ESD.

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Other records listing Starkey Laboratories, Inc. as applicant

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Related Devices (Code: ESD)

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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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