2ND SKIN MOIST BURN PADS WITH ALOE— 510(k) K911550

Substantially Equivalent

Spenco Medical Corp.

FDA 510(k) clearance K911550 for 2ND SKIN MOIST BURN PADS WITH ALOE, Substantially Equivalent on 1991-09-06. Applicant: Spenco Medical Corp..

Clearance details

Applicant: Spenco Medical Corp.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1991-04-08
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waco, TX, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.