The following data is part of a premarket notification filed by Mega Medical, Inc. with the FDA for Mega Amniocentesis Kit.
| Device ID | K915863 |
| 510k Number | K915863 |
| Device Name: | MEGA AMNIOCENTESIS KIT |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Contact | Ray Vahab |
| Correspondent | Ray Vahab MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| 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 | 1991-12-31 |
| Decision Date | 1992-03-30 |