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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 K770586
Device Name UNIVERSAL MOUTHPIECE, #750
Applicant
Surgicot, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Surgicot, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5620
Classification Product Code
BYP  
Date Received03/28/1977
Decision Date 04/05/1977
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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