VYGON RED-O-PACK— 510(k) K771015

Substantially Equivalent

Coastal Bend Medical Products, Inc.

FDA 510(k) clearance K771015 for VYGON RED-O-PACK, Substantially Equivalent on 1977-07-11. Applicant: Coastal Bend Medical Products, Inc..

Clearance details

Applicant: Coastal Bend Medical Products, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1977-06-06
Decision date: 1977-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.