Cleared Traditional

SEXUAL ASSAULT FORENCIC EVIDENCE KIT

K772298 · Simpson/Basye, Inc. · General Hospital
Mar 1978
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K772298 is an FDA 510(k) clearance for the SEXUAL ASSAULT FORENCIC EVIDENCE KIT, a Applicator, Absorbent Tipped, Non-sterile (Class I — General Controls, product code KXF), submitted by Simpson/Basye, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978, 79 days after receiving the submission on December 13, 1977. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number K772298 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1977
Decision Date March 02, 1978
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KXF — Applicator, Absorbent Tipped, Non-sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6025