510(k) K913621
K913621 is an FDA 510(k) premarket notification submitted by Rinn Dental Products for the device "RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code EAJ (Apron, Leaded), a Class I device regulated under 21 CFR 892.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1991
- Date Received
- August 13, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apron, Leaded
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type