The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Pad, Polyether Foam, Open Cell.
Device ID | K760315 |
510k Number | K760315 |
Device Name: | PAD, POLYETHER FOAM, OPEN CELL |
Classification | Bed, Manual |
Applicant | GAYMAR INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-26 |
Decision Date | 1976-08-11 |