Cleared Traditional

K882520 - SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS
(FDA 510(k) Clearance)

K882520 · Karlin Technology, Inc. · General & Plastic Surgery device

Jul 1988

Decision

31d

Days

Class 1

Risk

K882520 is an FDA 510(k) clearance for the SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS. This device is classified as a Surgical Table Cushion (Class I - General Controls, product code LWG).

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on July 18, 1988, 31 days after receiving the submission on June 17, 1988.

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

Submission Details

510(k) Number	K882520 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 1988
Decision Date	July 18, 1988
Days to Decision	31 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—