SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/

Pump, Infusion

SIGMA INTL.

The following data is part of a premarket notification filed by Sigma Intl. with the FDA for Sigma Syringe Delivery System(multi-doser Rev. 1/multi-doser Rev. Ii/single-doser Rev. 1-10/single-doser Rev. 1-20/.

Pre-market Notification Details

• Device ID: K962709
• 510k Number: K962709
• Device Name: SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
• Classification: Pump, Infusion
• Applicant: SIGMA INTL. 711 PARK AVE. Medina, NY 14103 -0756
• Contact: Patrick W Penque
• Correspondent: Patrick W Penque; SIGMA INTL. 711 PARK AVE. Medina, NY 14103 -0756
• Product Code: FRN
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-07-12
• Decision Date: 1996-10-07
• Summary: summary