The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Autogel Pad.
Device ID | K031018 |
510k Number | K031018 |
Device Name: | AUTOGEL PAD |
Classification | Media, Coupling, Ultrasound |
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 | MUI |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-31 |
Decision Date | 2003-12-08 |