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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K935755
Device Name THE ULTRA
Applicant
Medical Device Systems, Inc.
212 E. Park St.
Auburndale,  FL  33823
Applicant Contact JOHN S BODOLAY
Correspondent
Medical Device Systems, Inc.
212 E. Park St.
Auburndale,  FL  33823
Correspondent Contact JOHN S BODOLAY
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/26/1993
Decision Date 05/05/1995
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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