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510(k) K921053

Device
LAPAROMED LIGATING LOOP
Applicant
LAPAROMED CORP.
510(k) number
K921053
Product code
KCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-06
Date received
1992-03-05
Regulation
874.5220
Classification name
Applicator, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL LUBOCK
Address
9272 Jeronimo Rd., Unit 109 Irvine CA US 92718 92718

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923679ENDOPATH TISSUE RETAINING COMPONENTEthicon Endo-Surgery, Inc.1992-09-09
K894369APDYNE PHENOL APPLICATOR KITApdyne Medical Co.1989-10-12
K832667LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.1983-09-29

Legacy Summary#

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FDA Review#

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