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FDA 510(k)

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

K-Number: K972883 · 1998-02-26

ApplicantCypress Medical Products, Ltd.
Decision Date1998-02-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) is the device name listed in this FDA 510(k) record. The listed applicant is Cypress Medical Products, Ltd.. It received FDA 510(k) clearance on 1998-02-26 under 510(k) number K972883. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)?

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) is a medical device that received FDA 510(k) clearance on 1998-02-26. The listed applicant is Cypress Medical Products, Ltd.. The 510(k) number is K972883.

When did ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) receive FDA 510(k) clearance?

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) received FDA 510(k) clearance on 1998-02-26, under 510(k) number K972883.

Who is the listed applicant for ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)?

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

What is the FDA product code for ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)?

The FDA product code for ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) is FXX.

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Other records listing Cypress Medical 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.

K021676CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METALK012282STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVEK972899CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETERK972849ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)K952367CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVEK950254CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE

View all 26 devices →

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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