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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, surgical, ceiling mounted
510(k) Number K854922
Device Name AMSCO POLARIS SL
Applicant
AMSCO CO.
2424 WEST 23RD ST.
ERIE,  PA  16514
Applicant Contact JAMES A SPALLINA
Correspondent
AMSCO CO.
2424 WEST 23RD ST.
ERIE,  PA  16514
Correspondent Contact JAMES A SPALLINA
Regulation Number878.4580
Classification Product Code
FSY  
Date Received12/10/1985
Decision Date 01/24/1986
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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