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FDA 510(k)

CFR MONOGRAPH

K-Number: K925259 · 1993-01-11

ApplicantCombe, Inc.
Decision Date1993-01-11
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CFR MONOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Combe, Inc.. It received FDA 510(k) clearance on 1993-01-11 under 510(k) number K925259. The device is classified under product code EFT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CFR MONOGRAPH?

CFR MONOGRAPH is a medical device that received FDA 510(k) clearance on 1993-01-11. The listed applicant is Combe, Inc.. The 510(k) number is K925259.

When did CFR MONOGRAPH receive FDA 510(k) clearance?

CFR MONOGRAPH received FDA 510(k) clearance on 1993-01-11, under 510(k) number K925259.

Who is the listed applicant for CFR MONOGRAPH?

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 CFR MONOGRAPH?

The FDA product code for CFR MONOGRAPH is EFT.

Related Clinical Trials

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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 CLEANSERK863375SEA-BONDK780719FUNGUS FIGHTER INSOLESK770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYK770175SEA-BOND ADHEVISE DENTURE CUSHIONS

Related Devices (Code: EFT)

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.

K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLCK051342MEDICAL INTERPOROUSBonyf AGK000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.K942203OTC DENTURE CLEANSERCombe, Inc.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE PRODUCT XEssential Dental Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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