The following data is part of a premarket notification filed by Regenesis Biomedical, Inc. with the FDA for Regenesis Model 42.
| Device ID | K972093 |
| 510k Number | K972093 |
| Device Name: | REGENESIS MODEL 42 |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | REGENESIS BIOMEDICAL, INC. 12300 TWINBROOK PKWY, STE. 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey REGENESIS BIOMEDICAL, INC. 12300 TWINBROOK PKWY, STE. 625 Rockville, MD 20852 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-10-21 |
| Summary: | summary |