The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Sterilization Process/dbl. Grip Cord Clp.
Device ID | K792631 |
510k Number | K792631 |
Device Name: | STERILIZATION PROCESS/DBL. GRIP CORD CLP |
Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNA |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-19 |
Decision Date | 1980-01-28 |