CARETEX CENTRAL SUPPLY WRAP— 510(k) K883802

Name: FDA 510(k) clearance K883802
Creator: U.S. Food and Drug Administration
Published: 1988-10-21

Substantially Equivalent

James River Corp.

FDA 510(k) clearance K883802 for CARETEX CENTRAL SUPPLY WRAP, Substantially Equivalent on 1988-10-21. Applicant: James River Corp.. Device class: 2.

Clearance details

Applicant: James River Corp.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1988-09-07
Decision date: 1988-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, US

Download summary PDF View on FDA.gov ↗

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More clearances from James River Corp.

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K894505 — COTOLIN DRAIN SPONGE AND DRESSING SPONGE1989-09-15
K894147 — VISULIN TRANSPARENT ADHESIVE DRESSING1989-08-09
K892580 — CARETOUCH EXAMINATION GLOVES1989-07-14
K893939 — ISOLATION MASKS1989-07-14
K894034 — MODIFIED LABELING OF SURGICAL GLOVES1989-07-14

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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