The following data is part of a premarket notification filed by Carl Schuh with the FDA for Easy Trans Tip.
| Device ID | K982565 |
| 510k Number | K982565 |
| Device Name: | EASY TRANS TIP |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | CARL SCHUH 10915 LURLINE AVE. Chatsowrth, CA 91311 -1638 |
| Contact | Carl Schuh |
| Correspondent | Carl Schuh CARL SCHUH 10915 LURLINE AVE. Chatsowrth, CA 91311 -1638 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-23 |
| Decision Date | 1998-09-22 |
| Summary: | summary |