Cleared Traditional

K893452 - EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
(FDA 510(k) Clearance)

K893452 · Warner-Lambert Co. · Radiology
Jun 1989
Decision
50d
Days
Class 2
Risk

K893452 is an FDA 510(k) clearance for the EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM, a Table, Radiographic, Non-tilting, Powered (Class II — Special Controls, product code IZZ), submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on June 22, 1989, 50 days after receiving the submission on May 3, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K893452 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1989
Decision Date June 22, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IZZ — Table, Radiographic, Non-tilting, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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