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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K884722
Device Name LUMINEB I
Applicant
LUMISCOPE CO., INC.
400 RARITAN CENTER PKWY.
EDISON,  NJ  08837
Applicant Contact STEVEN RAY
Correspondent
LUMISCOPE CO., INC.
400 RARITAN CENTER PKWY.
EDISON,  NJ  08837
Correspondent Contact STEVEN RAY
Regulation Number868.6250
Classification Product Code
BTI  
Date Received11/10/1988
Decision Date 02/03/1989
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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