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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent
510(k) Number K921053
Device Name LAPAROMED LIGATING LOOP
Applicant
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Applicant Contact PAUL LUBOCK
Correspondent
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Correspondent Contact PAUL LUBOCK
Regulation Number874.5220
Classification Product Code
KCJ  
Date Received03/05/1992
Decision Date 08/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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