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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gauze/Sponge, Internal
510(k) Number K890727
Device Name NON-STERILE, BULK GAUZE SPONGES
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
Classification Product Code
EFQ  
Date Received02/13/1989
Decision Date 03/10/1989
Decision Substantially Equivalent (SESE)
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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