The following data is part of a premarket notification filed by Bio-dyne, Inc. with the FDA for Hemorx Cold Pack.
| Device ID | K883984 |
| 510k Number | K883984 |
| Device Name: | HEMORX COLD PACK |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | BIO-DYNE, INC. 7720 S. W. 175TH ST. Miami, FL 33157 |
| Contact | Richard A Carsillo |
| Correspondent | Richard A Carsillo BIO-DYNE, INC. 7720 S. W. 175TH ST. Miami, FL 33157 |
| 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 | 1988-09-20 |
| Decision Date | 1988-12-22 |