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FDA 510(k)

CHEMOSITE IMPLANTABLE DRUG DELIVERY

K-Number: K930632 · 1993-12-22

ApplicantDevice Labs, Inc.
Decision Date1993-12-22
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEMOSITE IMPLANTABLE DRUG DELIVERY is the device name listed in this FDA 510(k) record. The listed applicant is Device Labs, Inc.. It received FDA 510(k) clearance on 1993-12-22 under 510(k) number K930632. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMOSITE IMPLANTABLE DRUG DELIVERY?

CHEMOSITE IMPLANTABLE DRUG DELIVERY is a medical device that received FDA 510(k) clearance on 1993-12-22. The listed applicant is Device Labs, Inc.. The 510(k) number is K930632.

When did CHEMOSITE IMPLANTABLE DRUG DELIVERY receive FDA 510(k) clearance?

CHEMOSITE IMPLANTABLE DRUG DELIVERY received FDA 510(k) clearance on 1993-12-22, under 510(k) number K930632.

Who is the listed applicant for CHEMOSITE IMPLANTABLE DRUG DELIVERY?

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

What is the FDA product code for CHEMOSITE IMPLANTABLE DRUG DELIVERY?

The FDA product code for CHEMOSITE IMPLANTABLE DRUG DELIVERY is KMF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Device Labs, 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.

K904417CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEMK902135PERCUTANEOUS INTRODUCER KITK901722CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK883764INTRAVASCULAR ADMINISTRATION SETK882064LO-CORE NEEDLE

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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