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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K770708
Device Name TYGON PAC-STOPCOCKS
Applicant
Norton Performance Plastics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Norton Performance Plastics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FMG  
Date Received04/18/1977
Decision Date 06/08/1977
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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