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FDA 510(k)

LAP SPONGE

K-Number: K896801 · 1989-12-27

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1989-12-27
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

LAP SPONGE 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 1989-12-27 under 510(k) number K896801. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAP SPONGE?

LAP SPONGE is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896801.

When did LAP SPONGE receive FDA 510(k) clearance?

LAP SPONGE received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896801.

Who is the listed applicant for LAP SPONGE?

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 LAP SPONGE?

The FDA product code for LAP SPONGE is EFQ.

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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.

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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

View all 28 devices →

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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