SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA— 510(k) K971472

Substantially Equivalent

Technical Products, Inc.

FDA 510(k) clearance K971472 for SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA, Substantially Equivalent on 1997-07-01. Applicant: Technical Products, Inc..

Clearance details

Applicant: Technical Products, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 1997-04-23
Decision date: 1997-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Decatur, GA, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.