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FDA 510(k)

P.F.C. CEMENT PRESSURIZING SYSTEM

K-Number: K943906 · 1994-12-21

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1994-12-21
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. CEMENT PRESSURIZING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K943906. The device is classified under product code KIH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C. CEMENT PRESSURIZING SYSTEM?

P.F.C. CEMENT PRESSURIZING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K943906.

When did P.F.C. CEMENT PRESSURIZING SYSTEM receive FDA 510(k) clearance?

P.F.C. CEMENT PRESSURIZING SYSTEM received FDA 510(k) clearance on 1994-12-21, under 510(k) number K943906.

Who is the listed applicant for P.F.C. CEMENT PRESSURIZING SYSTEM?

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

What is the FDA product code for P.F.C. CEMENT PRESSURIZING SYSTEM?

The FDA product code for P.F.C. CEMENT PRESSURIZING SYSTEM is KIH.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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Related Devices (Code: KIH)

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.

K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica Corp.

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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