The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Invotec Ear Tampon (wick) W/string.
| Device ID | K973578 |
| 510k Number | K973578 |
| Device Name: | INVOTEC EAR TAMPON (WICK) W/STRING |
| Classification | Ear Wick |
| Applicant | INVOTEC INTERNATIONAL, INC. 11243-1 ST. JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 11243-1 ST. JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | KCN |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-11-06 |