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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor
510(k) Number K903969
Device Name SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
Applicant
KARLIN TECHNOLOGY, INC.
2730 MONTEREY ST, #104
TORRANCE,  CA  90503
Applicant Contact TOM MACK
Correspondent
KARLIN TECHNOLOGY, INC.
2730 MONTEREY ST, #104
TORRANCE,  CA  90503
Correspondent Contact TOM MACK
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/28/1990
Decision Date 09/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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