510(k) K853665
K853665 is an FDA 510(k) premarket notification submitted by Ohio Medical Research, Inc. for the device "SPLASH ADAPTOR". The FDA issued a decision of Substantially Equivalent on October 10, 1985. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1985
- Date Received
- September 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drain, Tee (Water Trap)
- Device Class
- Class I
- Regulation Number
- 868.5995
- Review Panel
- AN
- Submission Type