2ND SKIN NON-STICK MOIST BURN PADS— 510(k) K894898

Name: FDA 510(k) clearance K894898
Creator: U.S. Food and Drug Administration
Published: 1989-08-23

Substantially Equivalent

Spenco Medical Corp.

FDA 510(k) clearance K894898 for 2ND SKIN NON-STICK MOIST BURN PADS, Substantially Equivalent on 1989-08-23. Applicant: Spenco Medical Corp.. Device class: Unclassified.

Clearance details

Applicant: Spenco Medical Corp.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1989-08-01
Decision date: 1989-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waco, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spenco Medical Corp.

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K981902 — SPENCO SILICONE GEL SHEET1998-06-25
K922228 — 2ND SKIN STERILE ADHESIVE STRIP1992-12-11
K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE1991-09-06
K910927 — SPENCIO SKIN GUARD KIT1991-06-03
K896533 — SPENCO BREAST FORMS1989-12-13

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.