GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

Pump, Infusion, Elastomeric

PRINCETON REGULATORY ASSOC.

The following data is part of a premarket notification filed by Princeton Regulatory Assoc. with the FDA for Go Medical Patient Controlled Analgesia Devices.

Pre-market Notification Details

• Device ID: K972158
• 510k Number: K972158
• Device Name: GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
• Classification: Pump, Infusion, Elastomeric
• Applicant: PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799
• Contact: Thomas Becze
• Correspondent: Thomas Becze; PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799
• Product Code: MEB
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-09
• Decision Date: 1998-02-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09350902000334	K972158	000
09350902000303	K972158	000
09350902000273	K972158	000