The following data is part of a premarket notification filed by Cost Rite Health Products, Inc. with the FDA for Rubber Dam.
| Device ID | K890667 |
| 510k Number | K890667 |
| Device Name: | RUBBER DAM |
| Classification | Dam, Rubber |
| Applicant | COST RITE HEALTH PRODUCTS, INC. 9428 ETON AVE. UNIT "F" Chatsworth, CA 91311 |
| Contact | Ben-tzur |
| Correspondent | Ben-tzur COST RITE HEALTH PRODUCTS, INC. 9428 ETON AVE. UNIT "F" Chatsworth, CA 91311 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-03-29 |