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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K942002
Device Name RETRACTOR
Applicant
AUTOMATED MEDICAL PRODUCTS CORP.
2315 BROADWAY, SUITE 410
NEW YORK,  NY  10024
Applicant Contact GREGORY DIAMANT
Correspondent
AUTOMATED MEDICAL PRODUCTS CORP.
2315 BROADWAY, SUITE 410
NEW YORK,  NY  10024
Correspondent Contact GREGORY DIAMANT
Regulation Number878.4800
Classification Product Code
GAD  
Date Received04/25/1994
Decision Date 05/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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