The following data is part of a premarket notification filed by Aga Plastic Ind. Com. Ltda. with the FDA for Aromatic And Flavored Tongue Depressor.
| Device ID | K992995 |
| 510k Number | K992995 |
| Device Name: | AROMATIC AND FLAVORED TONGUE DEPRESSOR |
| Classification | Depressor, Tongue, Non-surgical |
| Applicant | AGA PLASTIC IND. COM. LTDA. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk AGA PLASTIC IND. COM. LTDA. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FMA |
| CFR Regulation Number | 880.6230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-12-09 |
| Summary: | summary |