INTERMITTENT INJECTION SITE— 510(k) K923323
Substantially EquivalentKawasumi Laboratories Co., Ltd.
FDA 510(k) clearance K923323 for INTERMITTENT INJECTION SITE, Substantially Equivalent on 1993-07-13. Applicant: Kawasumi Laboratories Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code FOZ
view allMore clearances from Kawasumi Laboratories Co., Ltd.
view all- K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET
- K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
- K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
- K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
- K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.