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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtools, Assisted Reproduction (Pipettes)
510(k) Number K993699
Device Name THE STRIPPER
Applicant
Mid-Atlantic Diagnostics, Inc.
338 Stokes Rd.
Medford,  NJ  08055
Applicant Contact TERRANCE J FORTINO
Correspondent
Mid-Atlantic Diagnostics, Inc.
338 Stokes Rd.
Medford,  NJ  08055
Correspondent Contact TERRANCE J FORTINO
Regulation Number884.6130
Classification Product Code
MQH  
Date Received11/02/1999
Decision Date 05/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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