VALVE CONTROLLER FOR MICROMACRO COMPOUNDER

Set, I.v. Fluid Transfer

BAXA CORP., SUB. OF COOK GROUP, INC.

The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Valve Controller For Micromacro Compounder.

Pre-market Notification Details

• Device ID: K903159
• 510k Number: K903159
• Device Name: VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
• Classification: Set, I.v. Fluid Transfer
• Applicant: BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood, CO 80112
• Contact: Mary Steggall
• Correspondent: Mary Steggall; BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood, CO 80112
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-18
• Decision Date: 1990-11-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412492051	K903159	000
50085412477294	K903159	000
50085412476716	K903159	000
55413765562735	K903159	000