IUP - TIP TRANS, IUP - PROXI TRANS— 510(k) K961290
Substantially EquivalentScientific Device Manufacturer, LLC
FDA 510(k) clearance K961290 for IUP - TIP TRANS, IUP - PROXI TRANS, Substantially Equivalent on 1996-10-15. Applicant: Scientific Device Manufacturer, LLC. Device class: 2.
Clearance details
- Applicant
- Scientific Device Manufacturer, LLC
- Product code
- Code KXO
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Rafael, CA, US
Recent devices under product code KXO
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- K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
- K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
More clearances from Scientific Device Manufacturer, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.