510(k) K915634
K915634 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS PD+ EXCHANGE DEVICE". The FDA issued a decision of Substantially Equivalent on July 1, 1993. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1993
- Date Received
- December 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type