BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP— 510(k) K993871
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K993871 for BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP, Substantially Equivalent on 2000-04-21. Applicant: Allegiance Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgraw Park, IL, US
Recent devices under product code FRG
view allMore clearances from Allegiance Healthcare Corp.
view all- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K023419 — TRILAMINATE DRAPES/TIBURON
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.