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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K980227
Device Name MANAN GALACTOGRAPHY KIT
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/22/1998
Decision Date 04/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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