Sun-Lite Blue Slit

FDA 510(k) K840492 · Suncoast Medical Manufacturers, Inc.

Substantially Equivalent

510(k) numberK840492

Submission

Device name
Sun-Lite Blue Slit
Applicant
Suncoast Medical Manufacturers, Inc.
Mchenry, IL, US
Received
February 6, 1984
Decision date
May 9, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTP – File
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HTP

510(k)DeviceApplicantDecision
K931733Intermedics Orthopedics ReamersHTP · Traditional Intermedics Orthopedics01/26/1994SE
K870842Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional Warsaw Orthopedic, Inc.05/27/1987SE
K862659Concept Arthroscopy RaspHTP · Traditional Concept, Inc.09/02/1986SE
K8419814MM & 5MM FileHTP · Traditional Stainless Mfg., Inc.06/19/1984SE

More from Stainless Mfg., Inc.

510(k)DeviceDecision
K841604Adjust-A-Temp High TemperatureGEI · Traditional 12/07/1984SE
K841603Adjust-A-Temp MicroGEI · Traditional 12/07/1984SE
K841509Replace-A-Tip Adjustable High Temp.GEI · Traditional 12/07/1984SE
K841459Replace-A-Tip Adjust. Low Temp.-GEI · Traditional 12/07/1984SE
K841591Pyro-TipGEI · Traditional 10/31/1984SE
K840376Surg-A Stat Loop TipGEI · Traditional 10/26/1984SE
K840387Surg-A-Stat Loop Tip 2GEI · Traditional 07/23/1984SE
K840377Surg-A-Stat Cardiovascular TipGEI · Traditional 07/23/1984SE
K840375Surg-A-Stat Loop Tip 15GEI · Traditional 07/23/1984SE
K840370Surg-A-Stat Vasectomy TipGET · Traditional 07/23/1984SE

Questions and answers

When was Sun-Lite Blue Slit cleared by the FDA?

Sun-Lite Blue Slit (K840492) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 93 days after the submission was received.

What is the product code of K840492?

The FDA product code is HTP – File, a Class I (low risk) device regulated under 21 CFR 888.4540.