BK-7182 INSTANT COLD PACK— 510(k) K813628

Name: FDA 510(k) clearance K813628
Creator: U.S. Food and Drug Administration
Published: 1982-01-19

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K813628 for BK-7182 INSTANT COLD PACK, Substantially Equivalent on 1982-01-19. Applicant: Fred Sammons, Inc.. Device class: 1.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1981-12-29
Decision date: 1982-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.