Cleared Traditional

GENERAL PROCEDURE KIT

K960248 · Physician Industries, Inc. · General Hospital
Apr 1996
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K960248 is an FDA 510(k) clearance for the GENERAL PROCEDURE KIT, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Physician Industries, Inc. (North Salt Lake, US). The FDA issued a Cleared decision on April 12, 1996, 87 days after receiving the submission on January 16, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K960248 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date April 12, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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