The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Us 610.
Device ID | K844036 |
510k Number | K844036 |
Device Name: | US 610 |
Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Product Code | IMI |
CFR Regulation Number | 890.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-16 |
Decision Date | 1984-11-27 |