Standard Supreme Sterilization Wrapper— 510(k) K172207

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K172207 for Standard Supreme Sterilization Wrapper, Substantially Equivalent on 2017-08-25. Applicant: Standard Textile Co., Inc..

Clearance details

Applicant
Standard Textile Co., Inc.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cincinnati, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

Source: openFDA MAUDE database, through . 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.