Cleared Traditional

COMPRESAID

K881516 · R. Evans Corp. · General & Plastic Surgery
Apr 1988
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K881516 is an FDA 510(k) clearance for the COMPRESAID, a Splint, Extremity, Inflatable, External (Class I — General Controls, product code FZF), submitted by R. Evans Corp. (Phoenix, US). The FDA issued a Cleared decision on April 29, 1988, 18 days after receiving the submission on April 11, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3900.

Submission Details

510(k) Number K881516 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1988
Decision Date April 29, 1988
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZF — Splint, Extremity, Inflatable, External
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.3900