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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen, non-rebreathing
510(k) Number K781414
Device Name MASK, OXYGEN, NONBREATHING
Applicant
VITALAB PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VITALAB PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5570
Classification Product Code
KGB  
Date Received08/15/1978
Decision Date 09/07/1978
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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