The following data is part of a premarket notification filed by Ontel Products Corp. with the FDA for Copper Tongue Scraper.
| Device ID | K980842 |
| 510k Number | K980842 |
| Device Name: | COPPER TONGUE SCRAPER |
| Classification | Scraper, Tongue |
| Applicant | ONTEL PRODUCTS CORP. 2 DANIEL RD. EAST Fairfield, NJ 07004 |
| Contact | Mike K Lakhiani |
| Correspondent | Mike K Lakhiani ONTEL PRODUCTS CORP. 2 DANIEL RD. EAST Fairfield, NJ 07004 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-04 |
| Decision Date | 1998-05-20 |
| Summary: | summary |