Cleared Traditional

LANCER BIOPSY HOLDER

K772149 · Sherwood Medical Industries · Pathology
Nov 1977
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K772149 is an FDA 510(k) clearance for the LANCER BIOPSY HOLDER, a Container, Embedding (Class I — General Controls, product code KER), submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977, 8 days after receiving the submission on November 14, 1977. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K772149 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1977
Decision Date November 22, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KER — Container, Embedding
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010