BODY BAND RESTRAINT STRAP SET— 510(k) K923107

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K923107 for BODY BAND RESTRAINT STRAP SET, Substantially Equivalent on 1992-11-27. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1992-06-25
Decision date: 1992-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario L4a 7x5, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.