Cleared Traditional

K874543 - MODEL OPO-32 IRRIGATION SLEEVE
(FDA 510(k) Clearance)

K874543 · Allergan, Inc. · Dental device
Jan 1988
Decision
72d
Days
Class 1
Risk

K874543 is an FDA 510(k) clearance for the MODEL OPO-32 IRRIGATION SLEEVE. This device is classified as a Syringe, Irrigating (dental) (Class I - General Controls, product code EIB).

Submitted by Allergan, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 14, 1988, 72 days after receiving the submission on November 3, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K874543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1987
Decision Date January 14, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIB — Syringe, Irrigating (dental)
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4565