The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Invotec Ear Drape.
| Device ID | K911039 |
| 510k Number | K911039 |
| Device Name: | INVOTEC EAR DRAPE |
| Classification | Drape, Surgical |
| Applicant | INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 11330-1ST. JOHN'S INDUSTRIAL PARKWAY Jacksonville, FL 32216 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-05-13 |