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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K870320
Device Name DACOMED PENILE PROSTHESIS SIZER
Applicant
Dacomed Corp.
1701 E. 79th St., Suite 17
Minneapolis,  MN  55425
Applicant Contact MARY M WILEN
Correspondent
Dacomed Corp.
1701 E. 79th St., Suite 17
Minneapolis,  MN  55425
Correspondent Contact MARY M WILEN
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/28/1987
Decision Date 03/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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