Cleared Traditional

K760791 - COOLEY ANGLED SCISSOR - 1MM PROBE POINT (FDA 510(k) Clearance)

Nov 1976
Decision
35d
Days
Class 1
Risk

K760791 is an FDA 510(k) clearance for the COOLEY ANGLED SCISSOR - 1MM PROBE POINT. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 11, 1976, 35 days after receiving the submission on October 7, 1976.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number K760791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1976
Decision Date November 11, 1976
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DWS — Instruments, Surgical, Cardiovascular
Device Class Class I - General Controls
CFR Regulation 21 CFR 870.4500