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FDA 510(k)

SHUR GEL 4

K-Number: K860855 · 1986-06-16

ApplicantColumbus Dental Mfg. Co.
Decision Date1986-06-16
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHUR GEL 4 is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Dental Mfg. Co.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K860855. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUR GEL 4?

SHUR GEL 4 is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K860855.

When did SHUR GEL 4 receive FDA 510(k) clearance?

SHUR GEL 4 received FDA 510(k) clearance on 1986-06-16, under 510(k) number K860855.

Who is the listed applicant for SHUR GEL 4?

The FDA 510(k) record lists Columbus Dental Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHUR GEL 4?

The FDA product code for SHUR GEL 4 is ELW.

Other records listing Columbus Dental Mfg. Co. as applicant

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Related Devices (Code: ELW)

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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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