Cleared Traditional

QS DELIVERY SYSTEM

K991254 · Sub-Q, Inc. · General Hospital
Aug 1999
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K991254 is an FDA 510(k) clearance for the QS DELIVERY SYSTEM, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Sub-Q, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 23, 1999, 132 days after receiving the submission on April 13, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K991254 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1999
Decision Date August 23, 1999
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960