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FDA 510(k)

A-COMPANY ELASTOMERIC TUBING

K-Number: K852599 · 1985-07-31

ApplicantA Company, Inc.
Decision Date1985-07-31
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-COMPANY ELASTOMERIC TUBING is the device name listed in this FDA 510(k) record. The listed applicant is A Company, Inc.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K852599. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-COMPANY ELASTOMERIC TUBING?

A-COMPANY ELASTOMERIC TUBING is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is A Company, Inc.. The 510(k) number is K852599.

When did A-COMPANY ELASTOMERIC TUBING receive FDA 510(k) clearance?

A-COMPANY ELASTOMERIC TUBING received FDA 510(k) clearance on 1985-07-31, under 510(k) number K852599.

Who is the listed applicant for A-COMPANY ELASTOMERIC TUBING?

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

What is the FDA product code for A-COMPANY ELASTOMERIC TUBING?

The FDA product code for A-COMPANY ELASTOMERIC TUBING is ECI.

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Other records listing A Company, 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.

K897195A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)K852600A-COMPANY ELASTOMERIC CHAIN DISPENSERK852596A-COMPANY ELASTIC LIGATURE RINGSK852598A-COMPANY SEPARATING ELASTICSK852800A-COMPANY SELF-LIGATING APPLIANCEK852670A-COMPANY ESPREE SAFETY HEADGEAR

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Related Devices (Code: ECI)

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.

K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.K980053GLENROE CHAINGlenroe TechnologiesK973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.

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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