The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Clearview Endoscope Cover.
| Device ID | K080740 |
| 510k Number | K080740 |
| Device Name: | CLEARVIEW ENDOSCOPE COVER |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. Jacksonville, FL 32256 -3029 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818501022394 | K080740 | 000 |