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)

BOUNDARY PROCESS CHANGE

K-Number: K812738 · 1981-11-16

ApplicantThe Buckeye Cellulose Corp.
Decision Date1981-11-16
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY PROCESS CHANGE is the device name listed in this FDA 510(k) record. The listed applicant is The Buckeye Cellulose Corp.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812738. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUNDARY PROCESS CHANGE?

BOUNDARY PROCESS CHANGE is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is The Buckeye Cellulose Corp.. The 510(k) number is K812738.

When did BOUNDARY PROCESS CHANGE receive FDA 510(k) clearance?

BOUNDARY PROCESS CHANGE received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812738.

Who is the listed applicant for BOUNDARY PROCESS CHANGE?

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

What is the FDA product code for BOUNDARY PROCESS CHANGE?

The FDA product code for BOUNDARY PROCESS CHANGE is KKX.

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 The Buckeye Cellulose 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.

K822925BOUNDARY SINGLE-USE GOWNSK823173ARRIRM SCRUB BRUSH/SPONGEK821564BOUNDARY PROCESS CHANGEK820758BOUNDARY SINGLE-USE CRANIOTOMY SHEETK820116BOUNDARYK813450BOUNDARY SINGLE-USE DRAPES

View all 18 devices →

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.

↑