DUREX, RAMSES, SHEIK
FDA 510(k) clearance K952415 · decided 1996-07-15
Clearance details
- K-number
- K952415
- Device name
- DUREX, RAMSES, SHEIK
- Applicant
- London International U.S. Holdings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-23
- Decision date
- 1996-07-15
- Days to decision
- 419 days
- Clearance type
- Traditional
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch London International U.S. Holdings
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.