The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Autoprism Infrared Lamp.
Device ID | K040679 |
510k Number | K040679 |
Device Name: | RICH-MAR AUTOPRISM INFRARED LAMP |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | RICH-MAR CORP. 15499 EAST 590TH RD. P.O. BOX 879 Inola, OK 74036 -0879 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. 15499 EAST 590TH RD. P.O. BOX 879 Inola, OK 74036 -0879 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-15 |
Decision Date | 2004-05-07 |