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FDA 510(k)

SEALITE

K-Number: K862284 · 1986-06-23

ApplicantSybron Corp.
Decision Date1986-06-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEALITE is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Corp.. It received FDA 510(k) clearance on 1986-06-23 under 510(k) number K862284. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALITE?

SEALITE is a medical device that received FDA 510(k) clearance on 1986-06-23. The listed applicant is Sybron Corp.. The 510(k) number is K862284.

When did SEALITE receive FDA 510(k) clearance?

SEALITE received FDA 510(k) clearance on 1986-06-23, under 510(k) number K862284.

Who is the listed applicant for SEALITE?

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

What is the FDA product code for SEALITE?

The FDA product code for SEALITE is EBC.

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Other records listing Sybron Corp. 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.

K854855PROOF ALGINATE IMPRESSION MATERIALK844092DIAGNOSTIC MICROSOPCE SLIDESK842132TYCOS SELF-CHECK/DIGITAL FEVER THERMOK841910KERR SEALAPEX ROOT CANAL SEALERK841732LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMK840407KERR RESIN BONDED BRIDGE CEMENT

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Related Devices (Code: EBC)

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.

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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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