The following data is part of a premarket notification filed by Bemis Health Care with the FDA for Bed Pan, Stackable (autoclavable).
Device ID | K760393 |
510k Number | K760393 |
Device Name: | BED PAN, STACKABLE (AUTOCLAVABLE) |
Classification | Bedpan |
Applicant | BEMIS HEALTH CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOB |
CFR Regulation Number | 880.6730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-06 |
Decision Date | 1976-08-23 |