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FDA 510(k)

INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT

K-Number: K935561 · 1994-01-26

ApplicantBausch & Lomb, Inc.
Decision Date1994-01-26
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K935561. The device is classified under product code JEQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT?

INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K935561.

When did INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT receive FDA 510(k) clearance?

INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT received FDA 510(k) clearance on 1994-01-26, under 510(k) number K935561.

Who is the listed applicant for INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT?

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

What is the FDA product code for INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT?

The FDA product code for INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT is JEQ.

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Other records listing Bausch & Lomb, Inc. as applicant

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Related Devices (Code: JEQ)

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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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