TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK— 510(k) K920162
Substantially EquivalentTecnol Medical Products, Inc.
FDA 510(k) clearance K920162 for TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK, Substantially Equivalent on 1993-01-27. Applicant: Tecnol Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Tecnol Medical Products, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code FXX
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- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Tecnol Medical Products, Inc.
view all- K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
- K970448 — PCM 2000; ISOLAIR APR MODEL 2735
- K963552 — QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
- K963559 — WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
- K963564 — PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.