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FDA 510(k)

DYNASTY IMPERVIOUS ISOLATION J-SUIT

K-Number: K923188 · 1993-01-29

ApplicantDynatech Medical Products
Decision Date1993-01-29
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DYNASTY IMPERVIOUS ISOLATION J-SUIT is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Medical Products. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K923188. 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 DYNASTY IMPERVIOUS ISOLATION J-SUIT?

DYNASTY IMPERVIOUS ISOLATION J-SUIT is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is Dynatech Medical Products. The 510(k) number is K923188.

When did DYNASTY IMPERVIOUS ISOLATION J-SUIT receive FDA 510(k) clearance?

DYNASTY IMPERVIOUS ISOLATION J-SUIT received FDA 510(k) clearance on 1993-01-29, under 510(k) number K923188.

Who is the listed applicant for DYNASTY IMPERVIOUS ISOLATION J-SUIT?

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

What is the FDA product code for DYNASTY IMPERVIOUS ISOLATION J-SUIT?

The FDA product code for DYNASTY IMPERVIOUS ISOLATION J-SUIT is FYC.

Related Clinical Trials

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Other records listing Dynatech Medical Products 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.

K923187IMPERVIOUS ISOLATION SHOE COVERSK922234DYNASTY ISOLATION GOWNK893520DR. BOO LATEX EXAMINATION GLOVESK770730PUMP, INFUSION, DYNATECH/HANDLEY

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

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