Shoulder Bolster, Knee, Ankle & Leg Support Pads

FDA 510(k) K882520 · Karlin Technology, Inc.

Substantially Equivalent

510(k) numberK882520

Submission

Device name
Shoulder Bolster, Knee, Ankle & Leg Support Pads
Applicant
Karlin Technology, Inc.
Marina Del Rey, CA, US
Received
June 17, 1988
Decision date
July 18, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LWG – Surgical Table Cushion
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Specialty
General, Plastic Surgery

Other 510(k)s with product code LWG

510(k)DeviceApplicantDecision
K883295Chop Spine FrameLWG · Traditional Avec Scientific Design Corp.08/23/1988SE
K874494Kambin Laminectomy FrameLWG · Traditional Avec Scientific Design Corp.11/23/1987SE
K873690Cedar(Tm) Pelvic CushionLWG · Traditional Cedar Surgical, Inc.10/26/1987SE

More from Cedar Surgical, Inc.

510(k)DeviceDecision
K903969Suction Retractor(Tower Attach.)For Crank Fram RetGAD · Traditional 09/05/1990SE
K893203Bone ScrewJDR · Traditional 04/04/1990SE
K893201Bone PlateHRS · Traditional 04/04/1990SE
K882525Spinal MicroknifeHTS · Traditional 09/22/1988SE
K882519X-Ray MarkerJAC · Traditional 08/09/1988SE
K882073Spinal NeedleGDM · Traditional 07/18/1988SE
K882524Universally Adjustable ArmboardBTX · Traditional 07/08/1988SE
K882077Microdiscectomy CurrettesLXH · Traditional 06/17/1988SE
K882072Orthopaedic and Spinal Ring CurrettesJXH · Traditional 06/17/1988SE
K882069Spinal Distractors, SpannersLXH · Traditional 06/17/1988SE

Questions and answers

When was Shoulder Bolster, Knee, Ankle & Leg Support Pads cleared by the FDA?

Shoulder Bolster, Knee, Ankle & Leg Support Pads (K882520) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 31 days after the submission was received.

What is the product code of K882520?

The FDA product code is LWG – Surgical Table Cushion, a Class I (low risk) device regulated under 21 CFR 878.4950.