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FDA 510(k)

ACUTEK'S CLEARPASAGE

K-Number: K962698 · 1996-09-09

ApplicantAcutek Adhesive Specialties, Inc.
Decision Date1996-09-09
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACUTEK'S CLEARPASAGE 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 1996-09-09 under 510(k) number K962698. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTEK'S CLEARPASAGE?

ACUTEK'S CLEARPASAGE is a medical device that received FDA 510(k) clearance on 1996-09-09. The listed applicant is Acutek Adhesive Specialties, Inc.. The 510(k) number is K962698.

When did ACUTEK'S CLEARPASAGE receive FDA 510(k) clearance?

ACUTEK'S CLEARPASAGE received FDA 510(k) clearance on 1996-09-09, under 510(k) number K962698.

Who is the listed applicant for ACUTEK'S CLEARPASAGE?

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 CLEARPASAGE?

The FDA product code for ACUTEK'S CLEARPASAGE is LWF.

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 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.

K974891ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013K974892ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012K974890ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002K951644ACUTEK'S CLEARPASSAGEK943111TRANSPARENT DRESSING

Related Devices (Code: LWF)

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.

K181219OptiPillows EPAP MaskCpapnea Medical SupplyK120665INVENT SNORING DEVICEVentus Medical, Inc.K040491CHIN-UP STRIPDale Miller, Inc. - the Chin-Up CompanyK982929MAXAIR NASAL DILATOR SYSTEMHnl TechnologiesK963326BREATHE FITCambridge Assoc.K962400AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, 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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