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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K921988
Device Name LACERATION REPAIR TRAY
Applicant
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact VARUN SONI
Correspondent
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact VARUN SONI
Regulation Number878.4800
Classification Product Code
MDM  
Date Received04/28/1992
Decision Date 11/19/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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