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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K833742
Device Name ESCHMANN DILATION CATHETER
Applicant
Vertex Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vertex Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received10/26/1983
Decision Date 04/24/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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