The following data is part of a premarket notification filed by Medical Appliance Research Corp. with the FDA for Zeroid Hemorrhoidal Device.
| Device ID | K944874 |
| 510k Number | K944874 |
| Device Name: | ZEROID HEMORRHOIDAL DEVICE |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | MEDICAL APPLIANCE RESEARCH CORP. 3780 N.E. 167TH ST. North Miami Beach, FL 33160 |
| Contact | Murray Cerami |
| Correspondent | Murray Cerami MEDICAL APPLIANCE RESEARCH CORP. 3780 N.E. 167TH ST. North Miami Beach, FL 33160 |
| Product Code | LKX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-08-07 |