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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 K873042
Device Name MODEL 1330 EXTENSION SET
Applicant
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact EDWARD NUMAINVILLE
Correspondent
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact EDWARD NUMAINVILLE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/04/1987
Decision Date 10/23/1987
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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