The following data is part of a premarket notification filed by Cost Rite Health Products, Inc. with the FDA for Carerite Biopack Gingival Retraction Cord.
| Device ID | K871736 |
| 510k Number | K871736 |
| Device Name: | CARERITE BIOPACK GINGIVAL RETRACTION CORD |
| Classification | Floss, Dental |
| 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 | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-05-27 |