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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, biological sterilization process
510(k) Number K905425
Device Name SPORVIEW
Applicant
SPS MEDICAL SUPPLY CORP.
1250 SCOTTSVILLE RD.
ROCHESTER,  NY  14624
Applicant Contact JACK SCOVILLE
Correspondent
SPS MEDICAL SUPPLY CORP.
1250 SCOTTSVILLE RD.
ROCHESTER,  NY  14624
Correspondent Contact JACK SCOVILLE
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/04/1990
Decision Date 03/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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