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FDA 510(k)

PENNINE DERBY YANKAUER

K-Number: K852079 · 1985-06-03

ApplicantPennine Medical , Ltd.
Decision Date1985-06-03
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PENNINE DERBY YANKAUER is the device name listed in this FDA 510(k) record. The listed applicant is Pennine Medical , Ltd.. It received FDA 510(k) clearance on 1985-06-03 under 510(k) number K852079. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENNINE DERBY YANKAUER?

PENNINE DERBY YANKAUER is a medical device that received FDA 510(k) clearance on 1985-06-03. The listed applicant is Pennine Medical , Ltd.. The 510(k) number is K852079.

When did PENNINE DERBY YANKAUER receive FDA 510(k) clearance?

PENNINE DERBY YANKAUER received FDA 510(k) clearance on 1985-06-03, under 510(k) number K852079.

Who is the listed applicant for PENNINE DERBY YANKAUER?

The FDA 510(k) record lists Pennine Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENNINE DERBY YANKAUER?

The FDA product code for PENNINE DERBY YANKAUER is BSY.

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Other records listing Pennine Medical , Ltd. 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.

K854443O'NEIL URINARY CATHETER INTRODUCERK852859PENNINE CONNECTING TUBINGK852081PENNINE OXYGEN LINK TUBINGK844874PENNINE LINK YANKAUERSK844876PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,K852080PENNINE SUCTION CATHETERS

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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