MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S

Introducer, Catheter

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Modification To:introducer Sets, Model Adelante And Adelante-s.

Pre-market Notification Details

• Device ID: K090114
• 510k Number: K090114
• Device Name: MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
• Classification: Introducer, Catheter
• Applicant: Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Contact: Mila Doskocil
• Correspondent: Mila Doskocil; Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-01-21
• Decision Date: 2009-06-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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