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FDA 510(k)

STERILE SURGICAL GOWN

K-Number: K895667 · 1989-10-13

ApplicantClinitech, Inc.
Decision Date1989-10-13
Product CodeFYE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Clinitech, Inc.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K895667. The device is classified under product code FYE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SURGICAL GOWN?

STERILE SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Clinitech, Inc.. The 510(k) number is K895667.

When did STERILE SURGICAL GOWN receive FDA 510(k) clearance?

STERILE SURGICAL GOWN received FDA 510(k) clearance on 1989-10-13, under 510(k) number K895667.

Who is the listed applicant for STERILE SURGICAL GOWN?

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

What is the FDA product code for STERILE SURGICAL GOWN?

The FDA product code for STERILE SURGICAL GOWN is FYE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Clinitech, 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.

K896367STERILE SURGICAL DRAPES AND SHEETSK864311STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)

Related Devices (Code: FYE)

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.

K932731BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.K912790SURGICAL GOWNUnicor Federal Dept. of JusticeK910920PROTEKT GLOVESIntermedics OrthopedicsK910941LIFELINER SURGICAL GLOVEDepuy-RaynhamK895235VARIOUS DISPOSABLE SURGICAL GARMENTSProtect Corp. of Indiana, Inc.K894760CLOTHINGUARDBarrier Concepts, 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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