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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K880338
Device Name CHICOPEE ADULT INCONTINENCE SHIELDS
Applicant
Chicopee, Inc.
2351 U.S. Rt. 130
P.O. Box 940
Dayton,  NJ  08810
Applicant Contact STANLEY L BURD
Correspondent
Chicopee, Inc.
2351 U.S. Rt. 130
P.O. Box 940
Dayton,  NJ  08810
Correspondent Contact STANLEY L BURD
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received01/26/1988
Decision Date 03/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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