The following data is part of a premarket notification filed by Calello Martinez P.c. with the FDA for Ayurvedic Tongue Cleaner.
| Device ID | K971025 |
| 510k Number | K971025 |
| Device Name: | AYURVEDIC TONGUE CLEANER |
| Classification | Scraper, Tongue |
| Applicant | CALELLO MARTINEZ P.C. 675 FRANKLIN AVE. Nutley, NJ 07110 -1209 |
| Contact | Antonio C Martinez, Ii |
| Correspondent | Antonio C Martinez, Ii CALELLO MARTINEZ P.C. 675 FRANKLIN AVE. Nutley, NJ 07110 -1209 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-05-22 |