Cleared Traditional

INFLATABLE AIR SPLINTS

K853600 · Hospitak, Inc. · General & Plastic Surgery
Sep 1985
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K853600 is an FDA 510(k) clearance for the INFLATABLE AIR SPLINTS, a Splint, Extremity, Inflatable, External (Class I — General Controls, product code FZF), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on September 19, 1985, 23 days after receiving the submission on August 27, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3900.

Submission Details

510(k) Number K853600 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1985
Decision Date September 19, 1985
Days to Decision 23 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