The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Handpico.
Device ID | K220041 |
510k Number | K220041 |
Device Name: | HandPICO |
Classification | Powered Laser Surgical Instrument |
Applicant | Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 CEP: 13.573-470 - Caixa Postal 772 Ceat - Sao Carlos/sp Sao Paulo, BR 13.573-470 |
Contact | Kathy Maynor |
Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-05 |
Decision Date | 2022-05-05 |