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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture Removal Kit
510(k) Number K924835
Device Name VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560
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 Number878.4800
Classification Product Code
MCZ  
Date Received09/25/1992
Decision Date 03/23/1993
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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