ACCO(R) FACE MASK— 510(k) K880613
Substantially EquivalentAbsorbent Cotton Co., Inc.
FDA 510(k) clearance K880613 for ACCO(R) FACE MASK, Substantially Equivalent on 1988-03-04. Applicant: Absorbent Cotton Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Absorbent Cotton Co., 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
- Hammonton, NJ, US
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- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Absorbent Cotton Co., Inc.
view allAdverse 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.