SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED— 510(k) K964398

Name: FDA 510(k) clearance K964398
Creator: U.S. Food and Drug Administration
Published: 1997-10-24

Substantially Equivalent

Polymedica Industries, Inc.

FDA 510(k) clearance K964398 for SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED, Substantially Equivalent on 1997-10-24. Applicant: Polymedica Industries, Inc.. Device class: Unclassified.

Clearance details

Applicant: Polymedica Industries, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-11-04
Decision date: 1997-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden,, CO, US

Download summary PDF View on FDA.gov ↗

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K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER1997-05-02
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K963623 — SPYROFLEX PIGMENTED WOUND DRESSING1996-10-25
K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER1996-09-12
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Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

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.