The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Bedpan, Single Patient Use, Tecnol.
Device ID | K760307 |
510k Number | K760307 |
Device Name: | BEDPAN, SINGLE PATIENT USE, TECNOL |
Classification | Bedpan |
Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
Product Code | FOB |
CFR Regulation Number | 880.6730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-26 |
Decision Date | 1976-08-11 |