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FDA 510(k)

CUTTER BOND POLYCARBOXYLATE CEMENT

K-Number: K821326 · 1982-05-28

ApplicantCutter Laboratories, Inc.
Decision Date1982-05-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUTTER BOND POLYCARBOXYLATE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821326. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTTER BOND POLYCARBOXYLATE CEMENT?

CUTTER BOND POLYCARBOXYLATE CEMENT is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K821326.

When did CUTTER BOND POLYCARBOXYLATE CEMENT receive FDA 510(k) clearance?

CUTTER BOND POLYCARBOXYLATE CEMENT received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821326.

Who is the listed applicant for CUTTER BOND POLYCARBOXYLATE CEMENT?

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

What is the FDA product code for CUTTER BOND POLYCARBOXYLATE CEMENT?

The FDA product code for CUTTER BOND POLYCARBOXYLATE CEMENT is EMA.

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Other records listing Cutter Laboratories, 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.

K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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