The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Teflon Uterine Sound.
| Device ID | K870550 |
| 510k Number | K870550 |
| Device Name: | TEFLON UTERINE SOUND |
| Classification | Sound, Uterine |
| Applicant | COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Dexter J Elkins |
| Correspondent | Dexter J Elkins COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | HHM |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-03-04 |