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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, physical/chemical sterilization process
510(k) Number K890761
Device Name STRIP, STERILIZATION INDICATOR; DRY HEAT
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
JOJ  
Date Received02/14/1989
Decision Date 08/07/1989
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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