Cleared Traditional

K873690 - CEDAR(TM) PELVIC CUSHION
(FDA 510(k) Clearance)

Oct 1987
Decision
48d
Days
Class 1
Risk

K873690 is an FDA 510(k) clearance for the CEDAR(TM) PELVIC CUSHION. This device is classified as a Surgical Table Cushion (Class I - General Controls, product code LWG).

Submitted by Cedar Surgical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 26, 1987, 48 days after receiving the submission on September 8, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K873690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date October 26, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code LWG — Surgical Table Cushion
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4950