Cleared Traditional

ACCUPEN(R)

K870078 · Ulster Scientific, Inc. · General Hospital
Mar 1987
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K870078 is an FDA 510(k) clearance for the ACCUPEN(R), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on March 17, 1987, 68 days after receiving the submission on January 8, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K870078 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1987
Decision Date March 17, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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