The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Sterilization Process/placenta Basin.
Device ID | K792625 |
510k Number | K792625 |
Device Name: | STERILIZATION PROCESS/PLACENTA BASIN |
Classification | Basin, Emesis |
Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNY |
CFR Regulation Number | 880.6730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-19 |
Decision Date | 1980-01-16 |