510(k) K873960
K873960 is an FDA 510(k) premarket notification submitted by Cheri Lewis, D.D.S. for the device "LEWIS SAFE SLEEVE". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code EIF (Accessories, Retractor, Dental), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1987
- Date Received
- September 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Retractor, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type