Cleared Traditional

HEM-O-LOK(TM)

K902108 · Edward Weck, Inc. · General & Plastic Surgery
Aug 1990
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K902108 is an FDA 510(k) clearance for the HEM-O-LOK(TM), a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on August 6, 1990, 90 days after receiving the submission on May 8, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K902108 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1990
Decision Date August 06, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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