0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS

Filter, Infusion Line

EVANS MEDICAL, INC.

The following data is part of a premarket notification filed by Evans Medical, Inc. with the FDA for 0.2. Micron Filter Sets And 1.2 Micron Filter Sets.

Pre-market Notification Details

• Device ID: K935641
• 510k Number: K935641
• Device Name: 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS
• Classification: Filter, Infusion Line
• Applicant: EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946
• Contact: David W. Evans
• Correspondent: David W. Evans; EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946
• Product Code: FPB
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-22
• Decision Date: 1994-01-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817708020205	K935641	000
00817708020182	K935641	000
00817708020168	K935641	000
00817708020144	K935641	000
00817708020120	K935641	000