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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
510(k) Number K924069
Device Name SURGICO OXYGEN MASK
Applicant
GUJARAT SURGICO, LTD.
A1, MALAV DUPLEX
STADIUM COMMERCE COLLELGE ROAD
NAVRANGPURA AHMEDABAD-380,  IN
Applicant Contact MANAGING DIRECTOR
Correspondent
GUJARAT SURGICO, LTD.
A1, MALAV DUPLEX
STADIUM COMMERCE COLLELGE ROAD
NAVRANGPURA AHMEDABAD-380,  IN
Correspondent Contact MANAGING DIRECTOR
Regulation Number868.5580
Classification Product Code
BYG  
Date Received08/11/1992
Decision Date 02/04/1993
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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