510(k) K922292
K922292 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "LUNDEEN SUBTALAR PEG IMPLANT". The FDA issued a decision of Substantially Equivalent on October 23, 1992. The device falls under product code MJW (Prosthesis, Subtalar, Plug, Polymer), a Class II device regulated under 21 CFR 888.3040. Sgarlato Laboratories, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1992
- Date Received
- May 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Subtalar, Plug, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type