The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Innervue Diagnostic Scope System.
| Device ID | K040604 |
| 510k Number | K040604 |
| Device Name: | INNERVUE DIAGNOSTIC SCOPE SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ARTHROTEK, INC. 56 EAST BELLE DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold ARTHROTEK, INC. 56 EAST BELLE DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304505995 | K040604 | 000 |