510(k) K915207
K915207 is an FDA 510(k) premarket notification submitted by Bay Technical Products, Inc. for the device "DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP". The FDA issued a decision of Substantially Equivalent on February 14, 1992. The device falls under product code EEF (Clamp, Rubber Dam), a Class I device regulated under 21 CFR 872.6300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1992
- Date Received
- November 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Rubber Dam
- Device Class
- Class I
- Regulation Number
- 872.6300
- Review Panel
- DE
- Submission Type