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FDA 510(k)

MODIFICATION TO TIELLE HYDROPOLMER DRESSING

K-Number: K983394 · 1998-11-03

ApplicantJohnson & Johnson Medical, Div. of Ethicon, Inc.
Decision Date1998-11-03
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TIELLE HYDROPOLMER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K983394. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO TIELLE HYDROPOLMER DRESSING?

MODIFICATION TO TIELLE HYDROPOLMER DRESSING is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. The 510(k) number is K983394.

When did MODIFICATION TO TIELLE HYDROPOLMER DRESSING receive FDA 510(k) clearance?

MODIFICATION TO TIELLE HYDROPOLMER DRESSING received FDA 510(k) clearance on 1998-11-03, under 510(k) number K983394.

Who is the listed applicant for MODIFICATION TO TIELLE HYDROPOLMER DRESSING?

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

What is the FDA product code for MODIFICATION TO TIELLE HYDROPOLMER DRESSING?

The FDA product code for MODIFICATION TO TIELLE HYDROPOLMER DRESSING is MGP.

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 Johnson & Johnson Medical, Div. of Ethicon, 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.

K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTK990395BARRIER SURGICAL GOWNSK983240NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVESK983234TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING

Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, Inc.

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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