Cleared Traditional

COTTON ROLL COMPRESSION CAPS

K792391 · Parker Laboratories, Inc. · Dental
Dec 1979
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K792391 is an FDA 510(k) clearance for the COTTON ROLL COMPRESSION CAPS, a Cotton, Roll (Class I — General Controls, product code EFN), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 10 days after receiving the submission on November 26, 1979. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K792391 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1979
Decision Date December 06, 1979
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EFN — Cotton, Roll
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050

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