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FDA 510(k)

CRYSTALCONE FACE MASK-MED-W/HOOKRING

K-Number: K834536 · 1984-01-25

ApplicantWarne Surgical Products, Ltd.
Decision Date1984-01-25
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRYSTALCONE FACE MASK-MED-W/HOOKRING is the device name listed in this FDA 510(k) record. The listed applicant is Warne Surgical Products, Ltd.. It received FDA 510(k) clearance on 1984-01-25 under 510(k) number K834536. 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 CRYSTALCONE FACE MASK-MED-W/HOOKRING?

CRYSTALCONE FACE MASK-MED-W/HOOKRING is a medical device that received FDA 510(k) clearance on 1984-01-25. The listed applicant is Warne Surgical Products, Ltd.. The 510(k) number is K834536.

When did CRYSTALCONE FACE MASK-MED-W/HOOKRING receive FDA 510(k) clearance?

CRYSTALCONE FACE MASK-MED-W/HOOKRING received FDA 510(k) clearance on 1984-01-25, under 510(k) number K834536.

Who is the listed applicant for CRYSTALCONE FACE MASK-MED-W/HOOKRING?

The FDA 510(k) record lists Warne Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTALCONE FACE MASK-MED-W/HOOKRING?

The FDA product code for CRYSTALCONE FACE MASK-MED-W/HOOKRING is BSJ.

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Other records listing Warne Surgical Products, Ltd. 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.

K850694WSP CODE 4310 STRESSCATHK850696WSP CODE 4300 DIOMASTER DIAGNOSTICK850695WSP CODE 4301 DIOMASTER THERAPEUTICK850693WSP CODE 4315 PADTESTK841511HAEMATURIA CATHETERSK840687KIDNEY TRANSPLANT CATHETER

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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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