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 |