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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 K963088
Device Name SHEATH, ELECTROSURGICAL PENCIL
Applicant
ASPEN LABORATORIES, INC.
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Applicant Contact CHARLES M HART
Correspondent
ASPEN LABORATORIES, INC.
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Correspondent Contact CHARLES M HART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/08/1996
Decision Date 09/13/1996
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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