The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Hle-1000 High/low Treatment Table.
Device ID | K883659 |
510k Number | K883659 |
Device Name: | HLE-1000 HIGH/LOW TREATMENT TABLE |
Classification | Table, Powered |
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 | INQ |
CFR Regulation Number | 890.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-26 |
Decision Date | 1988-10-13 |