Cleared Traditional

CPI PRINTER

K822857 · Cardiac Pacemakers, Inc. · General & Plastic Surgery
Jan 1983
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K822857 is an FDA 510(k) clearance for the CPI PRINTER, a Holder, Speculum, Ent (Class I — General Controls, product code KAG), submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983, 103 days after receiving the submission on September 27, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.1800.

Submission Details

510(k) Number K822857 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1982
Decision Date January 08, 1983
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KAG — Holder, Speculum, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.1800