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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saw, Surgical, Ent (Electric Or Pneumatic)
510(k) Number K800669
Device Name FELDMAN MINI-SAW, #300000
Applicant
KARL STORZ Endoscopy-America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
KARL STORZ Endoscopy-America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.4420
Classification Product Code
EWQ  
Date Received03/26/1980
Decision Date 04/21/1980
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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