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FDA 510(k)

SILICONE ELASTOMER KIT

K-Number: K810869 · 1981-04-29

ApplicantRapid Injection Systems Corp.
Decision Date1981-04-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILICONE ELASTOMER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Injection Systems Corp.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810869. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE ELASTOMER KIT?

SILICONE ELASTOMER KIT is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Rapid Injection Systems Corp.. The 510(k) number is K810869.

When did SILICONE ELASTOMER KIT receive FDA 510(k) clearance?

SILICONE ELASTOMER KIT received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810869.

Who is the listed applicant for SILICONE ELASTOMER KIT?

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

What is the FDA product code for SILICONE ELASTOMER KIT?

The FDA product code for SILICONE ELASTOMER KIT is EBI.

Related Clinical Trials

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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Other records listing Rapid Injection Systems 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.

K072479FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD

Related Devices (Code: EBI)

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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