Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SEA-BOND

K-Number: K863375 · 1986-09-19

ApplicantCombe, Inc.
Decision Date1986-09-19
Product CodeKXX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEA-BOND is the device name listed in this FDA 510(k) record. The listed applicant is Combe, Inc.. It received FDA 510(k) clearance on 1986-09-19 under 510(k) number K863375. The device is classified under product code KXX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEA-BOND?

SEA-BOND is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Combe, Inc.. The 510(k) number is K863375.

When did SEA-BOND receive FDA 510(k) clearance?

SEA-BOND received FDA 510(k) clearance on 1986-09-19, under 510(k) number K863375.

Who is the listed applicant for SEA-BOND?

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

What is the FDA product code for SEA-BOND?

The FDA product code for SEA-BOND is KXX.

Other records listing Combe, Inc. 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.

K942203OTC DENTURE CLEANSERK925259CFR MONOGRAPHK780719FUNGUS FIGHTER INSOLESK770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYK770175SEA-BOND ADHEVISE DENTURE CUSHIONS

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.

↑