The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Return Path Diathermy Handle.
| Device ID | K941495 |
| 510k Number | K941495 |
| Device Name: | RETURN PATH DIATHERMY HANDLE |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | MIRA, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson MIRA, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-07-15 |