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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K953484
Device Name POLLUX OA/POLLUX 30A/POLLUX 70A
Applicant
Pollux Endoscopy, Inc.
4696 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact PRECIOUS RESCH
Correspondent
Pollux Endoscopy, Inc.
4696 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact PRECIOUS RESCH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/25/1995
Decision Date 09/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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