The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Dt-iupc2 Transducer Tipped Dual Lumen Iup.
Device ID | K894362 |
510k Number | K894362 |
Device Name: | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP |
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 | 1989-07-14 |
Decision Date | 1989-08-15 |