TECNOL STIRRUPS STRAP— 510(k) K791859

Name: FDA 510(k) clearance K791859
Creator: U.S. Food and Drug Administration
Published: 1979-10-04

Substantially Equivalent

Tecnol New Jersey Wound Care, Inc.

FDA 510(k) clearance K791859 for TECNOL STIRRUPS STRAP, Substantially Equivalent on 1979-10-04. Applicant: Tecnol New Jersey Wound Care, Inc.. Device class: 1.

Clearance details

Applicant: Tecnol New Jersey Wound Care, Inc.
Product code: Code BWN
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1979-09-18
Decision date: 1979-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hammonton, NJ, US

Download summary PDF View on FDA.gov ↗

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K922288 — HOLDER, PEDIATRIC POSITION1993-02-10
K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M1991-04-02

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K913043 — MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS1991-08-23
K911891 — FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK1991-07-12
K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS1991-07-08
K896193 — TECNOL LAZER(TM) SURGICAL MASK1990-02-27
K894205 — TECNOL SILK STRIP1989-07-25

Adverse events under product code BWN

product code BWN

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.