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510(k) K914615

Device
BTP(TM) CENTRALINE(TM) SUIT
Applicant
BTP INDUSTRIES, INC.
510(k) number
K914615
Product code
FXO  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-05
Date received
1991-10-17
Regulation
878.4040
Classification name
Suit, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE A HERBSTER
Address
P.O. Box 2357 S. Hamilton MA US 01982 01982

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
K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEPro-Safe Professional Linens, Inc.1989-04-14
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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