The following data is part of a premarket notification filed by Custom Medical Arts, Inc. with the FDA for Breathtique Tongue Scraper.
| Device ID | K983087 |
| 510k Number | K983087 |
| Device Name: | BREATHTIQUE TONGUE SCRAPER |
| Classification | Scraper, Tongue |
| Applicant | CUSTOM MEDICAL ARTS, INC. 13882 NORTH KENDALL DR. Miami, FL 33186 |
| Contact | Barry Goldberg |
| Correspondent | Barry Goldberg CUSTOM MEDICAL ARTS, INC. 13882 NORTH KENDALL DR. Miami, FL 33186 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-03 |
| Decision Date | 1998-11-18 |