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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853037
Device Name DR. HESSEL'S VACUUM EXTRACTOR
Applicant
Medic Group of Scandinavia, Inc.
Federal Bar Bldg.
1815 H. St. NW Suite 501
Washington,  DC  20006
Applicant Contact RANDI L BRESLOW
Correspondent
Medic Group of Scandinavia, Inc.
Federal Bar Bldg.
1815 H. St. NW Suite 501
Washington,  DC  20006
Correspondent Contact RANDI L BRESLOW
Date Received07/18/1985
Decision Date 08/06/1985
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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