Cleared Traditional

IRRIGATION SYRINGE KIT

K982435 · Sub-Q, Inc. · General Hospital
Nov 1998
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K982435 is an FDA 510(k) clearance for the IRRIGATION SYRINGE KIT, 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 November 6, 1998, 116 days after receiving the submission on July 13, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K982435 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1998
Decision Date November 06, 1998
Days to Decision 116 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