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FDA 510(k)

PREMIER DECANNULATION STOPPER

K-Number: K884015 · 1988-11-03

ApplicantPremier Dental
Decision Date1988-11-03
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREMIER DECANNULATION STOPPER is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental. It received FDA 510(k) clearance on 1988-11-03 under 510(k) number K884015. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER DECANNULATION STOPPER?

PREMIER DECANNULATION STOPPER is a medical device that received FDA 510(k) clearance on 1988-11-03. The listed applicant is Premier Dental. The 510(k) number is K884015.

When did PREMIER DECANNULATION STOPPER receive FDA 510(k) clearance?

PREMIER DECANNULATION STOPPER received FDA 510(k) clearance on 1988-11-03, under 510(k) number K884015.

Who is the listed applicant for PREMIER DECANNULATION STOPPER?

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

What is the FDA product code for PREMIER DECANNULATION STOPPER?

The FDA product code for PREMIER DECANNULATION STOPPER is BTO.

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Related Devices (Code: BTO)

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.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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