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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, catheter
510(k) Number K820865
Device Name VAN-TEC FASCIAL DILATOR
Applicant
VAN-TEC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VAN-TEC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GCC  
Date Received03/29/1982
Decision Date 05/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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