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FDA 510(k)

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013

K-Number: K974891 · 1998-10-21

ApplicantAcutek Adhesive Specialties, Inc.
Decision Date1998-10-21
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 is the device name listed in this FDA 510(k) record. The listed applicant is Acutek Adhesive Specialties, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K974891. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013?

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Acutek Adhesive Specialties, Inc.. The 510(k) number is K974891.

When did ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 receive FDA 510(k) clearance?

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 received FDA 510(k) clearance on 1998-10-21, under 510(k) number K974891.

Who is the listed applicant for ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013?

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

What is the FDA product code for ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013?

The FDA product code for ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Acutek Adhesive Specialties, 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.

K974892ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012K974890ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002K962698ACUTEK'S CLEARPASAGEK951644ACUTEK'S CLEARPASSAGEK943111TRANSPARENT 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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