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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 K934252
Device Name RPPI STERILIZATION BAGS
Applicant
Royal Precision Plastics, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Royal Precision Plastics, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/31/1993
Decision Date 06/17/1994
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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