EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

Container, I.v.

SORENSON MEDICAL, INC.

The following data is part of a premarket notification filed by Sorenson Medical, Inc. with the FDA for Empty Reservoir Bag, 50 Ml,100 Ml,250 Ml,500 Ml, 1000m Ml, 1500 Ml, 2000 Ml, 3000 Ml.

Pre-market Notification Details

• Device ID: K001287
• 510k Number: K001287
• Device Name: EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
• Classification: Container, I.v.
• Applicant: SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320
• Contact: R. Douglas Jacob
• Correspondent: R. Douglas Jacob; SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320
• Product Code: KPE
• CFR Regulation Number: 880.5025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-24
• Decision Date: 2000-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20857595005866	K001287	000
20857595005842	K001287	000
20857595005835	K001287	000
20857595005736	K001287	000
20857595005125	K001287	000
20857595005118	K001287	000
10850000509235	K001287	000