Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PREMISE MODIFIED

K-Number: K090292 · 2009-04-03

ApplicantKerr Corp.
Decision Date2009-04-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMISE MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corp.. It received FDA 510(k) clearance on 2009-04-03 under 510(k) number K090292. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMISE MODIFIED?

PREMISE MODIFIED is a medical device that received FDA 510(k) clearance on 2009-04-03. The listed applicant is Kerr Corp.. The 510(k) number is K090292.

When did PREMISE MODIFIED receive FDA 510(k) clearance?

PREMISE MODIFIED received FDA 510(k) clearance on 2009-04-03, under 510(k) number K090292.

Who is the listed applicant for PREMISE MODIFIED?

The FDA 510(k) record lists Kerr Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMISE MODIFIED?

The FDA product code for PREMISE MODIFIED is EBF.

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 Kerr Corp. 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.

K091613TAKE 1K081695DMC COMPOSITEK072622STANDOUT 2K042888DEMETRON IDS CURING LIGHTK031484STAND OUTK014179DEMETRON LC

View all 9 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑