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FDA 510(k)

STERILE SUTURE BOOTS

K-Number: K834135 · 1984-04-27

ApplicantDevon Industries, Inc.
Decision Date1984-04-27
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SUTURE BOOTS is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1984-04-27 under 510(k) number K834135. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SUTURE BOOTS?

STERILE SUTURE BOOTS is a medical device that received FDA 510(k) clearance on 1984-04-27. The listed applicant is Devon Industries, Inc.. The 510(k) number is K834135.

When did STERILE SUTURE BOOTS receive FDA 510(k) clearance?

STERILE SUTURE BOOTS received FDA 510(k) clearance on 1984-04-27, under 510(k) number K834135.

Who is the listed applicant for STERILE SUTURE BOOTS?

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

What is the FDA product code for STERILE SUTURE BOOTS?

The FDA product code for STERILE SUTURE BOOTS is KDD.

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Other records listing Devon Industries, 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.

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK944114PHLEBOTOMY UNIT SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEM

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Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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