TECNOL BODY HOLDER— 510(k) K790699

Name: FDA 510(k) clearance K790699
Creator: U.S. Food and Drug Administration
Published: 1979-06-01

Substantially Equivalent

Tecnol New Jersey Wound Care, Inc.

FDA 510(k) clearance K790699 for TECNOL BODY HOLDER, Substantially Equivalent on 1979-06-01. Applicant: Tecnol New Jersey Wound Care, Inc.. Device class: 1.

Clearance details

Applicant: Tecnol New Jersey Wound Care, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1979-04-12
Decision date: 1979-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hammonton, NJ, US

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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 FMQ

product code FMQ

Death: 8
Total: 8

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.