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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Freezer
510(k) Number K913777
Device Name SELF-CONTAINED SURGICAL SLUSH FREEZER
Applicant
Taylor Corp.
750 N. Blackhawk Blvd.
Rockton,  IL  61072
Applicant Contact NORMAN L BECK
Correspondent
Taylor Corp.
750 N. Blackhawk Blvd.
Rockton,  IL  61072
Correspondent Contact NORMAN L BECK
Regulation Number862.2050
Classification Product Code
JRM  
Date Received08/14/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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