The following data is part of a premarket notification filed by Cheri Lewis, D.d.s. with the FDA for Lewis Safe Sleeve.
| Device ID | K873960 |
| 510k Number | K873960 |
| Device Name: | LEWIS SAFE SLEEVE |
| Classification | Accessories, Retractor, Dental |
| Applicant | CHERI LEWIS, D.D.S. 240 SOUTH LA CIENEGA BLVD. SUITE 301 Beverly Hills, CA 90211 |
| Contact | Lewis, D.d.s. |
| Correspondent | Lewis, D.d.s. CHERI LEWIS, D.D.S. 240 SOUTH LA CIENEGA BLVD. SUITE 301 Beverly Hills, CA 90211 |
| Product Code | EIF |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-28 |
| Decision Date | 1987-12-04 |