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510(k) K900487

Device
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K900487
Product code
GDH  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-09
Date received
1990-01-23
Regulation
878.4800
Classification name
Gouge, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVE REITZLER
Address
150 Glover Ave. Norwalk CT US 06856 06856

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903419MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVEUnited States Surgical, A Division of Tyco Healthc1990-08-09
K891901GOUGES, ALEXANDER, BISHOP, LUCASZinnanti Surgical Instruments, Inc.1989-04-12
K874879AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVEUnited States Surgical, A Division of Tyco Healthc1987-12-17
K842822CHERMEL BONE GOUGESCher Mel Corp.1984-08-02
K760850PARKES HUMP GAUGE STRAIGHT 7 (18 CM)V. Mueller O.V. Baxter Healthcare Corp.1976-11-03

Legacy Summary#

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FDA Review#

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