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FDA 510(k)

BLL-FIL 6140 PARTICLES

K-Number: K950511 · 1995-04-27

ApplicantBio-Interfaces, Inc.
Decision Date1995-04-27
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLL-FIL 6140 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 1995-04-27 under 510(k) number K950511. 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 BLL-FIL 6140 PARTICLES?

BLL-FIL 6140 PARTICLES is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K950511.

When did BLL-FIL 6140 PARTICLES receive FDA 510(k) clearance?

BLL-FIL 6140 PARTICLES received FDA 510(k) clearance on 1995-04-27, under 510(k) number K950511.

Who is the listed applicant for BLL-FIL 6140 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 BLL-FIL 6140 PARTICLES?

The FDA product code for BLL-FIL 6140 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-GRAFTK950567BIO-APATITE 6140 HA PARTICLESK933688BII-POREK934049BII-PORE(TM) CANAL WALL PROSTHESIS

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Related Devices (Code: LYC)

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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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