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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K901321
Device Name SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX
Applicant
Sharp Safe, Inc.
15777 W. Ten Mile
Suite 200
Southfield,  MI  48075
Applicant Contact J SAWAYA
Correspondent
Sharp Safe, Inc.
15777 W. Ten Mile
Suite 200
Southfield,  MI  48075
Correspondent Contact J SAWAYA
Classification Product Code
LDQ
Date Received03/21/1990
Decision Date 05/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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