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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K933852
Device Name PRO-LOK EXTENSION SET
Applicant
Beech Medical Products, Inc.
16 S. State St.
Newtown,  PA  18940
Applicant Contact JOHN ROMANO
Correspondent
Beech Medical Products, Inc.
16 S. State St.
Newtown,  PA  18940
Correspondent Contact JOHN ROMANO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/06/1993
Decision Date 12/29/1993
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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