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FDA 510(k)

QUALTEX SUTURE BOOTIES

K-Number: K911895 · 1991-05-08

ApplicantDeroyal Industries, Inc.
Decision Date1991-05-08
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX SUTURE BOOTIES is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1991-05-08 under 510(k) number K911895. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALTEX SUTURE BOOTIES?

QUALTEX SUTURE BOOTIES is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K911895.

When did QUALTEX SUTURE BOOTIES receive FDA 510(k) clearance?

QUALTEX SUTURE BOOTIES received FDA 510(k) clearance on 1991-05-08, under 510(k) number K911895.

Who is the listed applicant for QUALTEX SUTURE BOOTIES?

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

What is the FDA product code for QUALTEX SUTURE BOOTIES?

The FDA product code for QUALTEX SUTURE BOOTIES is MDM.

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Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, 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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