Cleared Traditional

SET, ORAL ADMINISTRATION

K760251 · Cis Radiopharmaceuticals, Inc. · General Hospital
Sep 1976
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K760251 is an FDA 510(k) clearance for the SET, ORAL ADMINISTRATION, a Set, Oral Administration (Class II — Special Controls, product code LEY), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1976, 58 days after receiving the submission on July 19, 1976. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K760251 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1976
Decision Date September 15, 1976
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LEY — Set, Oral Administration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980