LAP SPONGE— 510(k) K896801

Name: FDA 510(k) clearance K896801
Creator: U.S. Food and Drug Administration
Published: 1989-12-27

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896801 for LAP SPONGE, Substantially Equivalent on 1989-12-27. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps). Device class: Unclassified.

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1989-12-01
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

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K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
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K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

More clearances from Westmark, Sterile Packing Systems, Inc. (Sps)

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K896800 — IRRIGATION TRAY1990-05-24
K896799 — PARACERVICAL/PUDENDAL TRAYS1990-04-23
K896559 — INFANT FEEDING TUBE1990-03-13
K896794 — SPECIMEN CONTAINER1990-03-01
K896806 — CATHETER PLUG/PROTECTOR1990-02-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.