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FDA 510(k)

MODIFIED TOUCH-ME-NOT MASK

K-Number: K884157 · 1989-08-21

ApplicantWalt'S Products
Decision Date1989-08-21
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED TOUCH-ME-NOT MASK is the device name listed in this FDA 510(k) record. The listed applicant is Walt'S Products. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K884157. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED TOUCH-ME-NOT MASK?

MODIFIED TOUCH-ME-NOT MASK is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Walt'S Products. The 510(k) number is K884157.

When did MODIFIED TOUCH-ME-NOT MASK receive FDA 510(k) clearance?

MODIFIED TOUCH-ME-NOT MASK received FDA 510(k) clearance on 1989-08-21, under 510(k) number K884157.

Who is the listed applicant for MODIFIED TOUCH-ME-NOT MASK?

The FDA 510(k) record lists Walt'S Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED TOUCH-ME-NOT MASK?

The FDA product code for MODIFIED TOUCH-ME-NOT MASK is BSJ.

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Related Devices (Code: BSJ)

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.

K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing ConceptsK953295ANESTHESIA FACE MASKMallinckrodt MedicalK952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, 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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