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FDA 510(k)

POLY-MED DISPOSABLE PERSONAL PROTECTION KIT

K-Number: K930026 · 1993-10-04

ApplicantMedtek Development Corp.
Decision Date1993-10-04
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLY-MED DISPOSABLE PERSONAL PROTECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Development Corp.. It received FDA 510(k) clearance on 1993-10-04 under 510(k) number K930026. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-MED DISPOSABLE PERSONAL PROTECTION KIT?

POLY-MED DISPOSABLE PERSONAL PROTECTION KIT is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Medtek Development Corp.. The 510(k) number is K930026.

When did POLY-MED DISPOSABLE PERSONAL PROTECTION KIT receive FDA 510(k) clearance?

POLY-MED DISPOSABLE PERSONAL PROTECTION KIT received FDA 510(k) clearance on 1993-10-04, under 510(k) number K930026.

Who is the listed applicant for POLY-MED DISPOSABLE PERSONAL PROTECTION KIT?

The FDA 510(k) record lists Medtek Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLY-MED DISPOSABLE PERSONAL PROTECTION KIT?

The FDA product code for POLY-MED DISPOSABLE PERSONAL PROTECTION KIT is FYC.

Related Clinical Trials

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Other records listing Medtek Development Corp. 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.

K925077POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS

Related Devices (Code: FYC)

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.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

Official Source

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