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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K852078
Device Name SPECTRUM(TENTATIVE)
Applicant
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Applicant Contact CLEARY
Correspondent
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Correspondent Contact CLEARY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/13/1985
Decision Date 06/07/1985
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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