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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Cutting, Ent, Sterile
510(k) Number K950308
Device Name STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R. SAM NIEDBALA
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R. SAM NIEDBALA
Regulation Number874.3540
Classification Product Code
JXS  
Date Received01/25/1995
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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