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FDA 510(k)

DALE GASTROSTOMY TUBE HOLDER

K-Number: K961693 · 1996-07-30

ApplicantDale Medical Products, Inc.
Decision Date1996-07-30
Product CodePLI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DALE GASTROSTOMY TUBE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Dale Medical Products, Inc.. It received FDA 510(k) clearance on 1996-07-30 under 510(k) number K961693. The device is classified under product code PLI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DALE GASTROSTOMY TUBE HOLDER?

DALE GASTROSTOMY TUBE HOLDER is a medical device that received FDA 510(k) clearance on 1996-07-30. The listed applicant is Dale Medical Products, Inc.. The 510(k) number is K961693.

When did DALE GASTROSTOMY TUBE HOLDER receive FDA 510(k) clearance?

DALE GASTROSTOMY TUBE HOLDER received FDA 510(k) clearance on 1996-07-30, under 510(k) number K961693.

Who is the listed applicant for DALE GASTROSTOMY TUBE HOLDER?

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

What is the FDA product code for DALE GASTROSTOMY TUBE HOLDER?

The FDA product code for DALE GASTROSTOMY TUBE HOLDER is PLI.

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 Dale Medical Products, 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.

K082241THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751K994300NASOGASTRIC TUBE HOLDER, MODEL 160K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSK914245DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)K905231DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.

View all 13 devices →

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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