Cleared Traditional

K843796 - STERILE WATER (FDA 510(k) Clearance)

Dec 1984
Decision
74d
Days
Risk

K843796 is an FDA 510(k) clearance for the STERILE WATER..

Submitted by Paco Pharmaceutical Services, Inc. (Princeton, US). The FDA issued a Cleared decision on December 10, 1984, 74 days after receiving the submission on September 27, 1984.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K843796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date December 10, 1984
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code
Device Class