The following data is part of a premarket notification filed by Telos Medical Corp. with the FDA for Ultrans Disposable Intrauterine.
| Device ID | K882224 |
| 510k Number | K882224 |
| Device Name: | ULTRANS DISPOSABLE INTRAUTERINE |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
| Contact | TIMOTHY J TALCOTT |
| Correspondent | TIMOTHY J TALCOTT TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1989-10-12 |