The following data is part of a premarket notification filed by Leemart Bedding Mfg. Co. with the FDA for Bedding Pads Eggcreate Pads.
Device ID | K802781 |
510k Number | K802781 |
Device Name: | BEDDING PADS EGGCREATE PADS |
Classification | Mattress, Flotation Therapy, Non-powered |
Applicant | LEEMART BEDDING MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IKY |
CFR Regulation Number | 880.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-05 |
Decision Date | 1980-12-10 |