Cleared Traditional

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK

K951811 · Osteotech, Inc. · General & Plastic Surgery
May 1995
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K951811 is an FDA 510(k) clearance for the OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK, a Tray, Surgical (Class I — General Controls, product code LRP), submitted by Osteotech, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on May 31, 1995, 42 days after receiving the submission on April 19, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K951811 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1995
Decision Date May 31, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LRP — Tray, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800