FDA.reportPublic FDA data

510(k) K882282

Device
SUIT, SURGICAL
Applicant
A PLUS INTERNATIONAL, INC
510(k) number
K882282
Product code
FXO  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-23
Date received
1988-05-31
Regulation
878.4040
Classification name
Suit, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID LEE
Address
275 S. 3rd Ave. #2 La Puente CA US 91746 91746

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914615BTP(TM) CENTRALINE(TM) SUITBtp Industries, Inc.1992-05-05
K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEPro-Safe Professional Linens, Inc.1989-04-14
K865022SURGICAL GARMENTSUlti-Med Intl., Inc.1987-01-12
K831207SPUNGUARD SCRUB SUITKimberly-Clark Corp.1983-05-16
K822483MULTIPLE SCRUB SUITSurgilite Intl., Inc.1982-09-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases