The following data is part of a premarket notification filed by Mega Medical, Inc. with the FDA for Mega Paracentesis Kit.
| Device ID | K913382 |
| 510k Number | K913382 |
| Device Name: | MEGA PARACENTESIS KIT |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-10-08 |