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FDA 510(k)

ALLPAC(TM) MATERIAL

K-Number: K894759 · 1989-10-13

ApplicantBarrier Concepts, Inc.
Decision Date1989-10-13
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALLPAC(TM) MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Barrier Concepts, Inc.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K894759. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLPAC(TM) MATERIAL?

ALLPAC(TM) MATERIAL is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Barrier Concepts, Inc.. The 510(k) number is K894759.

When did ALLPAC(TM) MATERIAL receive FDA 510(k) clearance?

ALLPAC(TM) MATERIAL received FDA 510(k) clearance on 1989-10-13, under 510(k) number K894759.

Who is the listed applicant for ALLPAC(TM) MATERIAL?

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

What is the FDA product code for ALLPAC(TM) MATERIAL?

The FDA product code for ALLPAC(TM) MATERIAL is EIA.

Related Clinical Trials

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.

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Other records listing Barrier Concepts, 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.

K894760CLOTHINGUARD

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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