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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K893229
Device Name SPATULA FOR PAP SMEAR COLLECTION
Applicant
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number884.4530
Classification Product Code
HHT  
Date Received04/28/1989
Decision Date 02/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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