The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Intrauterine Sound, Plastic Disposable.
Device ID | K760170 |
510k Number | K760170 |
Device Name: | INTRAUTERINE SOUND, PLASTIC DISPOSABLE |
Classification | Sound, Uterine |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHM |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-07-19 |