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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K904271
Device Name OXLIFE
Applicant
MEDICAL REPAIR SERVICE, INC.
4470 HANCOCK BRIDGE PKWY.
N. FT. MYERS,  FL  33903
Applicant Contact STUART BASSINE
Correspondent
MEDICAL REPAIR SERVICE, INC.
4470 HANCOCK BRIDGE PKWY.
N. FT. MYERS,  FL  33903
Correspondent Contact STUART BASSINE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/17/1990
Decision Date 10/12/1990
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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