Cleared Traditional

ACU-LAB

K955776 · Glederer & Co., Inc. · General & Plastic Surgery
Jun 1996
Decision
168d
Days
Risk

About This 510(k) Submission

K955776 is an FDA 510(k) clearance for the ACU-LAB, submitted by Glederer & Co., Inc. (Paterson, US). The FDA issued a Cleared decision on June 5, 1996, 168 days after receiving the submission on December 20, 1995. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K955776 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1995
Decision Date June 05, 1996
Days to Decision 168 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LDQ
Device Class