84E SERIES SINGLE PLY WRAPPER— 510(k) K102864
Substantially EquivalentLac Mac, Ltd.
FDA 510(k) clearance K102864 for 84E SERIES SINGLE PLY WRAPPER, Substantially Equivalent on 2011-01-14. Applicant: Lac Mac, Ltd.. Device class: 2.
Clearance details
- Applicant
- Lac Mac, Ltd.
- 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
- Austin, TX, US
Recent devices under product code FRG
view allMore clearances from Lac Mac, Ltd.
view all- K092344 — LAC-MAC INNERBLOC LR SURGICAL GOWNS
- K061491 — LAC-MAC INNERBLOC O.R. GOWN
- K032631 — INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
- K031362 — LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
- K030536 — LAC-MAC LIMITED INNERBLOC O.R. GOWN
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.