The following data is part of a premarket notification filed by Cameo, Inc. with the FDA for Various Cameo Med Amniocentesis Trays, Disposable.
| Device ID | K922960 |
| 510k Number | K922960 |
| Device Name: | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| 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 | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1992-11-05 |