BIOTHANE PATIENT RESTRAINT— 510(k) K991591

Substantially Equivalent

Bioplastics

FDA 510(k) clearance K991591 for BIOTHANE PATIENT RESTRAINT, Substantially Equivalent on 1999-07-29. Applicant: Bioplastics.

Clearance details

Applicant: Bioplastics
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1999-05-07
Decision date: 1999-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Ridgeville, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.