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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Noninvasive
510(k) Number K832519
Device Name ASPIRATING TUBING
Applicant
Wells Johnson Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wells Johnson Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6740
Classification Product Code
GAZ  
Date Received08/08/1983
Decision Date 10/20/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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