Cleared Traditional

K833081 - ABSORABLE POLYGLACTIN 910-ANASTOMOTIC (FDA 510(k) Clearance)

Jan 1984
Decision
140d
Days
Risk

K833081 is an FDA 510(k) clearance for the ABSORABLE POLYGLACTIN 910-ANASTOMOTIC..

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on January 27, 1984, 140 days after receiving the submission on September 9, 1983.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K833081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1983
Decision Date January 27, 1984
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class