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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K911586
Device Name GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
Applicant
Megadyne Medical Products, Inc.
6202 Stratler St.
Murray,  UT  84107
Applicant Contact DREW D WEAVER
Correspondent
Megadyne Medical Products, Inc.
6202 Stratler St.
Murray,  UT  84107
Correspondent Contact DREW D WEAVER
Regulation Number880.6740
Classification Product Code
BYY  
Date Received04/09/1991
Decision Date 07/02/1991
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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