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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K844611
Device Name SINGLE BASIN SET
Applicant
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Applicant Contact ROBERT W FAIR
Correspondent
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Correspondent Contact ROBERT W FAIR
Regulation Number880.6850
Classification Product Code
FRG  
Date Received11/27/1984
Decision Date 12/19/1984
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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