Cleared Traditional

BYPASS COIL

K811068 · G.D. Searle and Co. · Radiology
May 1981
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K811068 is an FDA 510(k) clearance for the BYPASS COIL, a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981, 40 days after receiving the submission on April 17, 1981. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K811068 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1981
Decision Date May 27, 1981
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code KPY — Shield, Protective, Personnel
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500