MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
FDA 510(k) clearance K962273 · decided 1996-07-31
Clearance details
- K-number
- K962273
- Device name
- MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
- Applicant
- Marlo Surgical Technology
- Decision
- Substantially Equivalent
- Date received
- 1996-06-13
- Decision date
- 1996-07-31
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- MFD
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Willoughby, OH, US
- Third-party review
- No
- Expedited review
- No
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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.