510(k) K925754
K925754 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "ECONOM". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code EPY (Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1993
- Date Received
- November 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Ent
- Device Class
- Class I
- Regulation Number
- 878.1800
- Review Panel
- SU
- Submission Type