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FDA 510(k)

BIO-APATITE 6140 HA PARTICLES

K-Number: K950567 · 1995-05-09

ApplicantBio-Interfaces, Inc.
Decision Date1995-05-09
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-APATITE 6140 HA PARTICLES 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 1995-05-09 under 510(k) number K950567. 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-APATITE 6140 HA PARTICLES?

BIO-APATITE 6140 HA PARTICLES is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K950567.

When did BIO-APATITE 6140 HA PARTICLES receive FDA 510(k) clearance?

BIO-APATITE 6140 HA PARTICLES received FDA 510(k) clearance on 1995-05-09, under 510(k) number K950567.

Who is the listed applicant for BIO-APATITE 6140 HA PARTICLES?

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-APATITE 6140 HA PARTICLES?

The FDA product code for BIO-APATITE 6140 HA PARTICLES is LYC.

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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 6140K954763BIO-INTERFACES, INC,. BII-PLASTK950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTK950511BLL-FIL 6140 PARTICLESK933688BII-POREK934049BII-PORE(TM) CANAL WALL PROSTHESIS

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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.

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