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510(k) K865022

Device
SURGICAL GARMENTS
Applicant
ULTI-MED INTL., INC.
510(k) number
K865022
Product code
FXO  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-12
Date received
1986-12-23
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
JOHN FLOREN
Address
710 E. Remington Rd. Schaumburg IL US 60173 60173

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
K882282SUIT, SURGICALA Plus International, Inc.1988-06-23
K831207SPUNGUARD SCRUB SUITKimberly-Clark Corp.1983-05-16
K822483MULTIPLE SCRUB SUITSurgilite Intl., Inc.1982-09-17

Legacy Summary#

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FDA Review#

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