Cleared Traditional

HEMO-WEDGE

K790555 · Parker Laboratories, Inc. · Dental
Jan 1980
Decision
304d
Days
Class 1
Risk

About This 510(k) Submission

K790555 is an FDA 510(k) clearance for the HEMO-WEDGE, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980, 304 days after receiving the submission on March 19, 1979. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K790555 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1979
Decision Date January 17, 1980
Days to Decision 304 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZN — Instruments, Dental Hand
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565