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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sterilizer, Steam
510(k) Number K961230
Device Name EASTERCLAVE
Applicant
Easter Services, Inc.
306 W. Third St., 2nd. Floor
Milan,  IL  61264
Applicant Contact RANDY L BRUCE
Correspondent
Easter Services, Inc.
306 W. Third St., 2nd. Floor
Milan,  IL  61264
Correspondent Contact RANDY L BRUCE
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/29/1996
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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