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FDA 510(k)

SHAH SELF-CLEARING MASTOID SUCTION TUBE

K-Number: K853589 · 1985-12-23

ApplicantDowns Surgical , Ltd.
Decision Date1985-12-23
Product CodeJZF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHAH SELF-CLEARING MASTOID SUCTION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1985-12-23 under 510(k) number K853589. The device is classified under product code JZF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAH SELF-CLEARING MASTOID SUCTION TUBE?

SHAH SELF-CLEARING MASTOID SUCTION TUBE is a medical device that received FDA 510(k) clearance on 1985-12-23. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K853589.

When did SHAH SELF-CLEARING MASTOID SUCTION TUBE receive FDA 510(k) clearance?

SHAH SELF-CLEARING MASTOID SUCTION TUBE received FDA 510(k) clearance on 1985-12-23, under 510(k) number K853589.

Who is the listed applicant for SHAH SELF-CLEARING MASTOID SUCTION TUBE?

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

What is the FDA product code for SHAH SELF-CLEARING MASTOID SUCTION TUBE?

The FDA product code for SHAH SELF-CLEARING MASTOID SUCTION TUBE is JZF.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: JZF)

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.

K973587EXMOOR TYMPANOCENTESIS KIT (TK/1)Exmoor Plastics , Ltd.K862903MIDDLE EAR VIEWER AND FLUID COLLECTORSteven K. JuhnK841357MICRO FLUID APPLICATORTreace Medical, Inc.K822010RIGID SUCTION TIPS & RELATED ITEMSKelleher 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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