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FDA 510(k)

CLEANING SOLUTION, CATALOG NO. 8203

K-Number: K870759 · 1987-05-07

ApplicantTreace Medical, Inc.
Decision Date1987-05-07
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLEANING SOLUTION, CATALOG NO. 8203 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 1987-05-07 under 510(k) number K870759. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEANING SOLUTION, CATALOG NO. 8203?

CLEANING SOLUTION, CATALOG NO. 8203 is a medical device that received FDA 510(k) clearance on 1987-05-07. The listed applicant is Treace Medical, Inc.. The 510(k) number is K870759.

When did CLEANING SOLUTION, CATALOG NO. 8203 receive FDA 510(k) clearance?

CLEANING SOLUTION, CATALOG NO. 8203 received FDA 510(k) clearance on 1987-05-07, under 510(k) number K870759.

Who is the listed applicant for CLEANING SOLUTION, CATALOG NO. 8203?

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 CLEANING SOLUTION, CATALOG NO. 8203?

The FDA product code for CLEANING SOLUTION, CATALOG NO. 8203 is LRJ. This falls under the Clinical Lab category.

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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: LRJ)

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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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