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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 K971758
FOIA Releasable 510(k) K971758
Device Name CAUTERIZATION SMOKE EVACUATOR
Applicant
Applied Medical Technologies
15653 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact THOMAS W PARKINSON
Correspondent
Applied Medical Technologies
15653 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact THOMAS W PARKINSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/13/1997
Decision Date 07/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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