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FDA 510(k)

UNIVERSAL POOLE SUCTION TUBE

K-Number: K896556 · 1990-02-06

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1990-02-06
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL POOLE SUCTION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). It received FDA 510(k) clearance on 1990-02-06 under 510(k) number K896556. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL POOLE SUCTION TUBE?

UNIVERSAL POOLE SUCTION TUBE is a medical device that received FDA 510(k) clearance on 1990-02-06. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896556.

When did UNIVERSAL POOLE SUCTION TUBE receive FDA 510(k) clearance?

UNIVERSAL POOLE SUCTION TUBE received FDA 510(k) clearance on 1990-02-06, under 510(k) number K896556.

Who is the listed applicant for UNIVERSAL POOLE SUCTION TUBE?

The FDA 510(k) record lists Westmark, Sterile Packing Systems, Inc. (Sps) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL POOLE SUCTION TUBE?

The FDA product code for UNIVERSAL POOLE SUCTION TUBE is GCX.

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Other records listing Westmark, Sterile Packing Systems, Inc. (Sps) 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.

K896800IRRIGATION TRAYK896799PARACERVICAL/PUDENDAL TRAYSK896559INFANT FEEDING TUBEK896794SPECIMEN CONTAINERK896806CATHETER PLUG/PROTECTORK896798TRACHEOSTOMY TRAY

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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