SUB-Q SUBCUTANEOUS TISSUE INFUSION SET

Set, Administration, Intravascular

EMED TECHNOLOGIES CORPORATION

The following data is part of a premarket notification filed by Emed Technologies Corporation with the FDA for Sub-q Subcutaneous Tissue Infusion Set.

Pre-market Notification Details

• Device ID: K140131
• 510k Number: K140131
• Device Name: SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
• Classification: Set, Administration, Intravascular
• Applicant: EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct Ste 200 El Dorado Hills, CA 95762
• Contact: Peter Kollings
• Correspondent: Peter Kollings; EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct Ste 200 El Dorado Hills, CA 95762
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-17
• Decision Date: 2014-04-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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