The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Iup - Tip Trans, Iup - Proxi Trans.
Device ID | K961290 |
510k Number | K961290 |
Device Name: | IUP - TIP TRANS, IUP - PROXI TRANS |
Classification | Monitor, Pressure, Intrauterine |
Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Contact | Richard C Ball |
Correspondent | Richard C Ball SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Product Code | KXO |
CFR Regulation Number | 884.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-04 |
Decision Date | 1996-10-15 |
Summary: | summary |