510(k) K834143
K834143 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "NYLON COMPRESSION STUMP SHEATH". The FDA issued a decision of Substantially Equivalent on January 9, 1984. Ipos Luneburg has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1984
- Date Received
- December 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No