FDA 510(k)

EXMOOR TYMPANOCENTESIS KIT (TK/1)

K-Number: K973587 · 1998-01-23

Decision Date1998-01-23

Product CodeJZF

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

EXMOOR TYMPANOCENTESIS KIT (TK/1) is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K973587. 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 EXMOOR TYMPANOCENTESIS KIT (TK/1)?

EXMOOR TYMPANOCENTESIS KIT (TK/1) is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K973587.

When did EXMOOR TYMPANOCENTESIS KIT (TK/1) receive FDA 510(k) clearance?

EXMOOR TYMPANOCENTESIS KIT (TK/1) received FDA 510(k) clearance on 1998-01-23, under 510(k) number K973587.

Who is the listed applicant for EXMOOR TYMPANOCENTESIS KIT (TK/1)?

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

What is the FDA product code for EXMOOR TYMPANOCENTESIS KIT (TK/1)?

The FDA product code for EXMOOR TYMPANOCENTESIS KIT (TK/1) is JZF.

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Other records listing Exmoor Plastics , Ltd. as applicant

K093863EPIDRUM K990366EXMOOR SUCTION CLEARANCE KIT K980828EXMOOR MYRINGOTOMY KIT K981143DILKES LASER/SUCTION CANNULAE K972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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Related Devices (Code: JZF)

K862903MIDDLE EAR VIEWER AND FLUID COLLECTORSteven K. Juhn K853589SHAH SELF-CLEARING MASTOID SUCTION TUBEDowns Surgical , Ltd.K841357MICRO 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.