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FDA 510(k)

MODIFIED CUSHION-FLEX(TM)

K-Number: K890108 · 1989-01-24

ApplicantLife Design Systems, Inc.
Decision Date1989-01-24
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED CUSHION-FLEX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K890108. 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 CUSHION-FLEX(TM)?

MODIFIED CUSHION-FLEX(TM) is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K890108.

When did MODIFIED CUSHION-FLEX(TM) receive FDA 510(k) clearance?

MODIFIED CUSHION-FLEX(TM) received FDA 510(k) clearance on 1989-01-24, under 510(k) number K890108.

Who is the listed applicant for MODIFIED CUSHION-FLEX(TM)?

The FDA 510(k) record lists Life Design Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED CUSHION-FLEX(TM)?

The FDA product code for MODIFIED CUSHION-FLEX(TM) is BSJ.

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Other records listing Life Design Systems, 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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