Cleared Special

TISSU TRANS HARVEST TUBING

K092022 · Shippert Medical Technologies Corp. · General Hospital
Aug 2009
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K092022 is an FDA 510(k) clearance for the TISSU TRANS HARVEST TUBING, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on August 17, 2009, 42 days after receiving the submission on July 6, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K092022 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2009
Decision Date August 17, 2009
Days to Decision 42 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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