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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Scrub, Operating-Room
510(k) Number K810337
Device Name PDI SURGICAL SCRUB SPONGE-BRUSH-T15070
Applicant
Nice-Pak Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nice-Pak Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GEC  
Date Received02/09/1981
Decision Date 02/26/1981
Decision Substantially Equivalent (SESE)
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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