The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Amnicathdl(tm) Dt-iupc2 Dual Lumen Trans. Tipped.
| Device ID | K896122 |
| 510k Number | K896122 |
| Device Name: | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-01-19 |