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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K910362
Device Name TRACHEOSTOMY CARE KIT
Applicant
Megadyne Medical Products, Inc.
400 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact ELLEN JOY
Correspondent
Megadyne Medical Products, Inc.
400 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact ELLEN JOY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received01/29/1991
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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