510(k) K911407
K911407 is an FDA 510(k) premarket notification submitted by Harding Medical Devices for the device "HARDING STERNAL SHIELD". The FDA issued a decision of Substantially Equivalent on July 5, 1991. The device falls under product code EYF (Protector, Wound, Plastic), a Class I device regulated under 21 CFR 878.4014.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 1991
- Date Received
- March 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Wound, Plastic
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- SU
- Submission Type