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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laryngoscope, rigid
510(k) Number K961832
Device Name BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
Applicant
BLUE RIDGE MEDICAL, INC.
P.O. BOX 8664
GRAY,  TN  37615
Applicant Contact MARK J RICE
Correspondent
BLUE RIDGE MEDICAL, INC.
P.O. BOX 8664
GRAY,  TN  37615
Correspondent Contact MARK J RICE
Regulation Number868.5540
Classification Product Code
CCW  
Date Received05/13/1996
Decision Date 09/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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