FDA 510(k) Premarket Notification K092413: INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES

Submission Details & Decision

Normalized public record details for 510(k) notification K092413.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K092413

Applicant / Sponsor

Inviro Medical Devices, Inc.

Device Name

INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES

Product Code

MEG

Decision Date

2009-09-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Special

Third Party Flag

Date Received

2009-08-07

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