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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K952204
Device Name CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES
Applicant
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Applicant Contact IRA D DUESLER, JR
Correspondent
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Correspondent Contact IRA D DUESLER, JR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/10/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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