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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K925214
Device Name SHAVE PREP TRAYS (NON-STERILE)
Applicant
American Healthcare Supply Co., Inc.
6 Ingersoll Rd.
P.O. Box 544
South Plainfield,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
American Healthcare Supply Co., Inc.
6 Ingersoll Rd.
P.O. Box 544
South Plainfield,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number878.4370
Classification Product Code
LRO  
Date Received10/16/1992
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
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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