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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthpiece, Breathing
510(k) Number K803069
Device Name SHELL KRATON THERMO-PLASTIC RUBBER COMP.
Applicant
WARREN E. COLLINS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WARREN E. COLLINS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5620
Classification Product Code
BYP  
Date Received12/05/1980
Decision Date 12/22/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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