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510(k) K891212

Device
APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE
Applicant
PRO-SAFE PROFESSIONAL LINENS, INC.
510(k) number
K891212
Product code
FXO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-14
Date received
1989-03-07
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
SCOTT KAFKA
Address
304 W. Main St. Grand Junction CO US 81501 81501

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
K882282SUIT, SURGICALA Plus International, Inc.1988-06-23
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#

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FDA Review#

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