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FDA 510(k)

BIO-PREP CEMENT RESTRICTOR

K-Number: K931847 · 1994-06-28

ApplicantBiomedical Devices, Inc.
Decision Date1994-06-28
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIO-PREP CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Devices, Inc.. It received FDA 510(k) clearance on 1994-06-28 under 510(k) number K931847. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-PREP CEMENT RESTRICTOR?

BIO-PREP CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1994-06-28. The listed applicant is Biomedical Devices, Inc.. The 510(k) number is K931847.

When did BIO-PREP CEMENT RESTRICTOR receive FDA 510(k) clearance?

BIO-PREP CEMENT RESTRICTOR received FDA 510(k) clearance on 1994-06-28, under 510(k) number K931847.

Who is the listed applicant for BIO-PREP CEMENT RESTRICTOR?

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

What is the FDA product code for BIO-PREP CEMENT RESTRICTOR?

The FDA product code for BIO-PREP CEMENT RESTRICTOR is LZN.

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Other records listing Biomedical Devices, 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.

K955439THE REEL THING (MODIFICATION)K931846BIO-PREPK925982BMD AIR/OXYGEN BLENDERK903533STERI-SHIELDK902677STERI-SHIELDK830605PUMP PALL AMBULATORY INSULIN INFUSION

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Related Devices (Code: LZN)

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.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NV

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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