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510(k) K844152

Device
Hemstats
Applicant
I M, INC.
510(k) number
K844152
Product code
HRQ
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-07
Date received
1984-10-24
Regulation
878.4800
Classification name
Hemostat
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BERNARD E LADERMAN
Address
P.O. Box 658 Fairfield NJ US 07004 07004

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
K920298DISPOSABLE HEMOSTATSFalcon Instruments, Inc.1992-08-11
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
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