510(k) K883576
K883576 is an FDA 510(k) premarket notification submitted by Horizon Medical, Inc. for the device "HORIZON ORTHOPEDIC PIN PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030. Horizon Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1988
- Date Received
- August 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixation Accessory
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type