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510(k) K920298

Device
DISPOSABLE HEMOSTATS
Applicant
FALCON INSTRUMENTS, INC.
510(k) number
K920298
Product code
HRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-11
Date received
1992-01-22
Regulation
878.4800
Classification name
Hemostat
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NEAL DUNNING
Address
8309 Bryant Dr. Bethesda MD US 20817 20817

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895683BERNARD VESSEL APPROXIMATORApplied Medical Technologies1989-10-24
K890245SURGICAL HEMOSTATSKinetic Medical Products1989-01-27
K884196SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)Disposable Sterile Surgical Instruments, Inc.1988-11-08
K881937SURGICAL INSTRUMENTSFar East Intl. Trading Corp.1988-06-15
K861807MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)Medcomp Technologies, Inc.1986-05-23
K844152HEMSTATSI M, Inc.1984-11-07
K843593SURGIPRESS SURGICAL LOOPSyntex Corp.1984-10-24
K841514SCANLAN VASCU-STATT II APPROXIMATORScanlan Intl., Inc.1984-06-05
K834175OP-CON SURG. INSTRUMENTS #11Imm Enterprises , Ltd.1984-01-27
K831797HEMOSTATSI M, Inc.1983-07-19
K823694VASCU-STATT APPROXIMATORScanlan Intl., Inc.1983-01-07
K822263VARIOUS TYPES OF TONSILS HEMOSTATSKelleher Corp.1982-08-16
K821887SCANLAN SUTURE-STATTScanlan Intl., Inc.1982-07-28
K821617DISPOSABLE HEMOSTATSMedcare Products1982-06-21

Legacy Summary#

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FDA Review#

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