SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)

Monitor, Pressure, Intrauterine

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Softrans Intrauterine Pressure Catheter System (iup 4000 Softrans Iupc).

Pre-market Notification Details

• Device ID: K964279
• 510k Number: K964279
• Device Name: SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
• Classification: Monitor, Pressure, Intrauterine
• Applicant: GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271
• Contact: Kathleen H Selover
• Correspondent: Kathleen H Selover; GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271
• Product Code: KXO
• CFR Regulation Number: 884.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-28
• Decision Date: 1997-01-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884527004901	K964279	000
10884521164260	K964279	000