SYNERGY CT PICC

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

HEALTH LINE INTERNATIONAL CORPORATION

The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Synergy Ct Picc.

Pre-market Notification Details

• Device ID: K101329
• 510k Number: K101329
• Device Name: SYNERGY CT PICC
• Classification: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
• Applicant: HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014
• Contact: Nola Benstog
• Correspondent: Nola Benstog; HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014
• Product Code: LJS
• CFR Regulation Number: 880.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-12
• Decision Date: 2010-08-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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