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FDA 510(k)

ARMSTRONG V TUBE SUCTION INSERTER

K-Number: K822349 · 1982-09-13

ApplicantTreace Medical, Inc.
Decision Date1982-09-13
Product CodeJYM
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ARMSTRONG V TUBE SUCTION INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1982-09-13 under 510(k) number K822349. The device is classified under product code JYM. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARMSTRONG V TUBE SUCTION INSERTER?

ARMSTRONG V TUBE SUCTION INSERTER is a medical device that received FDA 510(k) clearance on 1982-09-13. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822349.

When did ARMSTRONG V TUBE SUCTION INSERTER receive FDA 510(k) clearance?

ARMSTRONG V TUBE SUCTION INSERTER received FDA 510(k) clearance on 1982-09-13, under 510(k) number K822349.

Who is the listed applicant for ARMSTRONG V TUBE SUCTION INSERTER?

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

What is the FDA product code for ARMSTRONG V TUBE SUCTION INSERTER?

The FDA product code for ARMSTRONG V TUBE SUCTION INSERTER is JYM.

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Other records listing Treace Medical, 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: JYM)

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.

K924901DEANS DISPOSABLE T-TUBE INSERTERExmoor Plastics , Ltd.K870978T-TUBE INSERTERSur-Med Instruments, Inc.K822348TYTAN TUBE INSERTERTreace Medical, 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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