Cleared Traditional

K780880 - Y-TYPE BLOOD SET (FDA 510(k) Clearance)

Jun 1978
Decision
31d
Days
Class 1
Risk

K780880 is an FDA 510(k) clearance for the Y-TYPE BLOOD SET. This device is classified as a Instrument, Surgical, Disposable (Class I - General Controls, product code KDC).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 30, 1978, 31 days after receiving the submission on May 30, 1978.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K780880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date June 30, 1978
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

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