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)

BIO-INTERFACES, INC,. BII-PLAST

K-Number: K954763 · 1996-01-04

ApplicantBio-Interfaces, Inc.
Decision Date1996-01-04
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-INTERFACES, INC,. BII-PLAST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Interfaces, Inc.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K954763. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-INTERFACES, INC,. BII-PLAST?

BIO-INTERFACES, INC,. BII-PLAST is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K954763.

When did BIO-INTERFACES, INC,. BII-PLAST receive FDA 510(k) clearance?

BIO-INTERFACES, INC,. BII-PLAST received FDA 510(k) clearance on 1996-01-04, under 510(k) number K954763.

Who is the listed applicant for BIO-INTERFACES, INC,. BII-PLAST?

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

What is the FDA product code for BIO-INTERFACES, INC,. BII-PLAST?

The FDA product code for BIO-INTERFACES, INC,. BII-PLAST is LYC.

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 Bio-Interfaces, 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.

K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140K950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTK950567BIO-APATITE 6140 HA PARTICLESK950511BLL-FIL 6140 PARTICLESK933688BII-POREK934049BII-PORE(TM) CANAL WALL PROSTHESIS

View all 17 devices →

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑