The following data is part of a premarket notification filed by General Clinical Plastics Corp. with the FDA for Disposable Bedpan.
Device ID | K791346 |
510k Number | K791346 |
Device Name: | DISPOSABLE BEDPAN |
Classification | Bedpan |
Applicant | GENERAL CLINICAL PLASTICS CORP. 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 | 1979-07-12 |
Decision Date | 1979-08-03 |