510(k) K803165
K803165 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ACETABULAR CEMENT COMPRESSOR". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code HXO (Pusher, Socket), a Class I device regulated under 21 CFR 888.4540. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1980
- Date Received
- December 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pusher, Socket
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type