Cleared Traditional

CUSTOM CV PACK

K936255 · Associated Medical · General & Plastic Surgery
Mar 1994
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K936255 is an FDA 510(k) clearance for the CUSTOM CV PACK, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Associated Medical (Minnetonka, US). The FDA issued a Cleared decision on March 31, 1994, 91 days after receiving the submission on December 30, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K936255 FDA.gov
FDA Decision Cleared SN
Date Received December 30, 1993
Decision Date March 31, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDD — Kit, Surgical Instrument, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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