QUICKPIN

Set, I.v. Fluid Transfer

LABORATORIOS GRIFOLS, S.A.

The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Quickpin.

Pre-market Notification Details

• Device ID: K082752
• 510k Number: K082752
• Device Name: QUICKPIN
• Classification: Set, I.v. Fluid Transfer
• Applicant: LABORATORIOS GRIFOLS, S.A. POL. LEVANTE C/CAN GUASCH, 2 Parets Del Valles, Barcelona, ES 08150
• Contact: Sebastian Gascon
• Correspondent: Stefan Preiss; TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-09-19
• Decision Date: 2008-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38426314734562	K082752	000