GLASS VAN GLASS SYRINGES— 510(k) K963364
Substantially EquivalentMyco Medical Supplies, Inc.
FDA 510(k) clearance K963364 for GLASS VAN GLASS SYRINGES, Substantially Equivalent on 1998-05-01. Applicant: Myco Medical Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Myco Medical Supplies, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Recent devices under product code FMF
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view all- K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
- K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
- K090426 — VAKU-8 BLOOD COLLECTION NEEDLES
- K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
- K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.