The following data is part of a premarket notification filed by Cameo, Inc. with the FDA for Various Cameo Med Percutaneous Skin Prep Trays,.
| Device ID | K922961 |
| 510k Number | K922961 |
| Device Name: | VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS, |
| Classification | Drape, Surgical |
| Applicant | CAMEO, INC. P.O. BOX 525 Toledo, OH 43693 |
| Contact | Robert Fedynich |
| Correspondent | Robert Fedynich CAMEO, INC. P.O. BOX 525 Toledo, OH 43693 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1993-03-23 |