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 |