The following data is part of a premarket notification filed by Theratechnologies, Inc. with the FDA for Eradic-all.
| Device ID | K981171 |
| 510k Number | K981171 |
| Device Name: | ERADIC-ALL |
| Classification | Unit, Operative Dental |
| Applicant | THERATECHNOLOGIES, INC. 630,BOUL. RENE-LEVESQUE QUEST 5E ETAGE Montreal Quebec, CA H3b 1s6 |
| Contact | Andre De Villers |
| Correspondent | Andre De Villers THERATECHNOLOGIES, INC. 630,BOUL. RENE-LEVESQUE QUEST 5E ETAGE Montreal Quebec, CA H3b 1s6 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-01 |
| Decision Date | 1998-12-02 |
| Summary: | summary |