510(k) K981855
K981855 is an FDA 510(k) premarket notification submitted by Prince Medical, Inc. for the device "PRINCE MEDICAL CEMENT PLUG". The FDA issued a decision of Substantially Equivalent on Aug 10, 1998. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 1998
- Date Received
- May 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type
- 510(k)