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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K953089
Device Name I-SPOUSE
Applicant
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Applicant Contact GREG HOLLAND
Correspondent
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Correspondent Contact GREG HOLLAND
Regulation Number878.4040
Classification Product Code
LYU  
Date Received07/03/1995
Decision Date 10/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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