510(k) K853119
K853119 is an FDA 510(k) premarket notification submitted by Dantec Electronics, Inc. for the device "URODYN 1000". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code FFO (Retractor, Self-Retaining), a Class I device regulated under 21 CFR 876.4730. Dantec Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1985
- Date Received
- July 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Self-Retaining
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type