Cleared Traditional

K791970 - HYGENIC RUBBER DAM LUBRICANT
(FDA 510(k) Clearance)

K791970 · The Hygenic Corp. · General Hospital
Nov 1979
Decision
45d
Days
Class 1
Risk

K791970 is an FDA 510(k) clearance for the HYGENIC RUBBER DAM LUBRICANT. This device is classified as a Lubricant, Patient (Class I — General Controls, product code KMJ).

Submitted by The Hygenic Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979, 45 days after receiving the submission on October 2, 1979.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K791970 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1979
Decision Date November 16, 1979
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KMJ — Lubricant, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6375