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FDA 510(k)

FISSURE SEALER & BONDING AGENT

K-Number: K813091 · 1981-11-24

ApplicantSci-Pharm, Inc.
Decision Date1981-11-24
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FISSURE SEALER & BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sci-Pharm, Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813091. 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 FISSURE SEALER & BONDING AGENT?

FISSURE SEALER & BONDING AGENT is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Sci-Pharm, Inc.. The 510(k) number is K813091.

When did FISSURE SEALER & BONDING AGENT receive FDA 510(k) clearance?

FISSURE SEALER & BONDING AGENT received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813091.

Who is the listed applicant for FISSURE SEALER & BONDING AGENT?

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

What is the FDA product code for FISSURE SEALER & BONDING AGENT?

The FDA product code for FISSURE SEALER & BONDING AGENT is EBC.

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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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