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510(k) K891901

Device
GOUGES, ALEXANDER, BISHOP, LUCAS
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891901
Product code
GDH  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-12
Date received
1989-03-24
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
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

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
K900487MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVEUnited States Surgical, A Division of Tyco Healthc1990-02-09
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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