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Found 2 results

510(k) Data Aggregation

K Number

Device Name

BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140

Manufacturer

BIO-INTERFACES, INC.

Date Cleared

1996-04-10

(85 days)

Product Code

LYC

Regulation Number

872.3930

Why did this record match?

Applicant Name (Manufacturer) :

BIO-INTERFACES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Not Found

Device Description

Bii-GRAFT™ 6140 Bioresorbable Calcium Particles are an osteoconductive biomatrix that approximates the chemical constituent of natural bone. The physical form of the material is particulate particles in the range of 105-250u. The nominal composition is 75 percent HA.

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K Number

Device Name

BIO-INTERFACES, INC,. BII-PLAST

Manufacturer

BIO-INTERFACES, INC.

Date Cleared

1996-01-04

(79 days)

Product Code

LYC

Regulation Number

872.3930

Why did this record match?

Applicant Name (Manufacturer) :

BIO-INTERFACES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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