REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.— 510(k) K882684

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K882684 for REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS., Substantially Equivalent on 1988-08-03. Applicant: Standard Textile Co., Inc..

Clearance details

Applicant: Standard Textile Co., Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1988-06-30
Decision date: 1988-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.