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FDA 510(k)

CARETEX SURGEON'S CAPS

K-Number: K880481 · 1988-02-24

ApplicantJames River Corp.
Decision Date1988-02-24
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARETEX SURGEON'S CAPS is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K880481. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARETEX SURGEON'S CAPS?

CARETEX SURGEON'S CAPS is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is James River Corp.. The 510(k) number is K880481.

When did CARETEX SURGEON'S CAPS receive FDA 510(k) clearance?

CARETEX SURGEON'S CAPS received FDA 510(k) clearance on 1988-02-24, under 510(k) number K880481.

Who is the listed applicant for CARETEX SURGEON'S CAPS?

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

What is the FDA product code for CARETEX SURGEON'S CAPS?

The FDA product code for CARETEX SURGEON'S CAPS is FYF.

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Other records listing James River 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.

K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEK894147VISULIN TRANSPARENT ADHESIVE DRESSINGK892580CARETOUCH EXAMINATION GLOVESK893939ISOLATION MASKSK894034MODIFIED LABELING OF SURGICAL GLOVESK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

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Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, 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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