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FDA 510(k)

DEXIDE ENDO-LUBE KIT

K-Number: K953611 · 1995-09-15

ApplicantDexide, Inc.
Decision Date1995-09-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEXIDE ENDO-LUBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dexide, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953611. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXIDE ENDO-LUBE KIT?

DEXIDE ENDO-LUBE KIT is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Dexide, Inc.. The 510(k) number is K953611.

When did DEXIDE ENDO-LUBE KIT receive FDA 510(k) clearance?

DEXIDE ENDO-LUBE KIT received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953611.

Who is the listed applicant for DEXIDE ENDO-LUBE KIT?

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

What is the FDA product code for DEXIDE ENDO-LUBE KIT?

The FDA product code for DEXIDE ENDO-LUBE KIT is GCJ.

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Other records listing Dexide, Inc. as applicant

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Related Devices (Code: GCJ)

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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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