SHAVE PREP TRAYS (NON-STERILE)

General Surgery Tray

AMERICAN HEALTHCARE SUPPLY CO., INC.

The following data is part of a premarket notification filed by American Healthcare Supply Co., Inc. with the FDA for Shave Prep Trays (non-sterile).

Pre-market Notification Details

Device IDK925214
510k NumberK925214
Device Name:SHAVE PREP TRAYS (NON-STERILE)
ClassificationGeneral Surgery Tray
Applicant AMERICAN HEALTHCARE SUPPLY CO., INC. 6 INGERSOLL RD. P.O. BOX 544 South Plainfield,  NJ  07080
ContactRalph S Jarrett
CorrespondentRalph S Jarrett
AMERICAN HEALTHCARE SUPPLY CO., INC. 6 INGERSOLL RD. P.O. BOX 544 South Plainfield,  NJ  07080
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-16
Decision Date1993-07-02

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