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510(k) K810188

Device
AUTO SUTURE GAS POWERED DISP. LDS STAPL
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K810188
Product code
KBC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-20
Date received
1981-01-22
Regulation
874.4420
Classification name
Saw, Nasal
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KBC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811887SKIN STAPLE EXTRACTORSierra Laboratories, Inc.1981-07-27
K810187AUTO SUTURE PSS SKIN STAPLING INSTRUMENTUnited States Surgical, A Division of Tyco Healthc1981-03-20
K772379JOSEPH SAWEdward Weck, Inc.1978-02-02

Legacy Summary#

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FDA Review#

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